मूलभूत आँकड़े
| LEI | 54930007YV6NYIOGFZ57 |
| CIK | 1735438 |
SEC Filings
All companies that sell securities in the United States must register with the Securities and Exchange Commission (SEC) and file reports on a regular basis.
These reports include company annual reports (10K, 10Q), news updates (8K), investor presentations (found in 8Ks), insider trades (form 4), ownership reports (13D, and 13G), and reports related to the specific securities sold, such as registration statements and prospectus. This page shows recent SEC filings related to MeiraGTx Holdings plc
SEC Filings (Chronological Order)
यह पृष्ठ SEC फाइलिंग की एक पूरी, कालानुक्रमिक सूची प्रदान करता है, ओनरशिप फाइलिंग को छोड़कर, जो हम अन्यत्र प्रदान करते हैं।
| August 14, 2025 |
Exhibit 99.1 MeiraGTx Reports Second Quarter 2025 Financial and Operational Results - Gained alignment with U.S. Food and Drug Administration (FDA) on the ongoing Phase 2 AQUAx2 randomized double-blind, placebo-controlled pivotal study in Grade 2/3 radiation-induced xerostomia (RIX) to support a potential Biologics License Application (BLA) filing; on track for potential data readout late 2026 - F |
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| August 14, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K Current Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): August 14, 2025 MeiraGTx Holdings plc (Exact name of registrant as specified in its charter) Cayman Islands 001-38520 98-1448305 (State or other jurisdiction of incorporation or organ |
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| August 14, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q 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, 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: 00 |
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| June 26, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K Current Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): June 26, 2025 MeiraGTx Holdings plc (Exact name of registrant as specified in its charter) Cayman Islands 001-38520 98-1448305 (State or other jurisdiction of incorporation or organiz |
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| June 17, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K Current Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): June 12, 2025 MeiraGTx Holdings plc (Exact name of registrant as specified in its charter) Cayman Islands 001-38520 98-1448305 (State or other jurisdiction of incorporation or organiz |
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| May 13, 2025 |
Lease Agreement, dated March 31, 2025, between MeiraGTx, LLC and ARE-East River Science Park, LLC. Exhibit 10.1 Execution Version Certain information marked as [***] has been excluded from this exhibit because it is both not material and is the type that the registrant treats as private or confidential. LEASE AGREEMENT THIS LEASE AGREEMENT is made as of this 31st day of March, 2025, between ARE-EAST RIVER SCIENCE PARK, LLC, a Delaware limited liability company (“Landlord”), and MEIRAGTX, LLC, a |
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| May 13, 2025 |
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 - |
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| May 13, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K Current Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): May 13, 2025 MeiraGTx Holdings plc (Exact name of registrant as specified in its charter) Cayman Islands 001-38520 98-1448305 (State or other jurisdiction of incorporation or organiza |
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| May 13, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q 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, 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: 0 |
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| May 9, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K Current Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): May 9, 2025 MeiraGTx Holdings plc (Exact name of registrant as specified in its charter) Cayman Islands 001-38520 98-1448305 (State or other jurisdiction of incorporation or organizat |
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| May 9, 2025 |
Exhibit 99.1 MeiraGTx Granted FDA Regenerative Medicine Advanced Therapy (RMAT) Designation for AAV-GAD for the Treatment of Parkinson’s Disease -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, |
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| April 30, 2025 |
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 (Amendment No. ) Filed by the Registrant ☒ Filed by a Party other than the Registrant ☐ Check the appropriate box: ☐ Preliminary Proxy Statement ☐ Confidential, for Use of the Commission Only (as permitted by Rule 14 |
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| April 30, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 (Amendment No. ) Filed by the Registrant ☒ Filed by a Party other than the Registrant ☐ Check the appropriate box: ☐ Preliminary Proxy Statement ☐ Confidential, for Use of the Commission Only (as permitted by Rule 14a-6(e)(2)) ☐ Defin |
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| April 4, 2025 |
Entry into a Material Definitive Agreement, Termination of a Material Definitive Agreement UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K Current Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): March 31, 2025 MeiraGTx Holdings plc (Exact name of registrant as specified in its charter) Cayman Islands 001-38520 98-1448305 (State or other jurisdiction of incorporation or organi |
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| March 13, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K 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, 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 MEIRAGT |
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| March 13, 2025 |
Exhibit 10.24 EXECUTION VERSION Certain information marked as [***] has been excluded from this exhibit because it is both (i) not material and (ii) is the type that the registrant customarily and actually treats as private or confidential. COLLABORATION, OPTION AND LICENSE AGREEMENT BY AND BETWEEN Janssen Pharmaceuticals, Inc., MEIRAGTX UK II LIMITED AND MEIRAGTX HOLDINGS PLC TABLE OF CONTENTS 1. |
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| March 13, 2025 |
As filed with the Securities and Exchange Commission on March 13, 2025 As filed with the Securities and Exchange Commission on March 13, 2025 Registration No. |
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| March 13, 2025 |
Exhibit 10.51 EXECUTION VERSION Certain information marked as [***] has been excluded from this exhibit because it is both not material and is the type that the registrant treats as private or confidential. MEIRAGTX MANUFACTURING LIMITED FRAMEWORK AGREEMENT Dated as of March 9, 2025 TABLE OF CONTENTS Page 1. DEFINITIONS 2 2. FORMATION AND PURPOSE 12 2.1 Formation 12 2.2 Name 12 2.3 Registered Offi |
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| March 13, 2025 |
MeiraGTx Holdings plc Insider Trading Compliance Policy. Exhibit 19.1 MEIRAGTX HOLDINGS PLC INSIDER TRADING COMPLIANCE POLICY This Insider Trading Compliance Policy (this “Policy”) consists of seven sections: · Section I provides an overview; · Section II sets forth the policies of the Company prohibiting insider trading; · Section III consists of procedures that have been put in place by the Company to prevent insider trading; · Section IV explains ins |
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| March 13, 2025 |
Exhibit 99.2 MeiraGTx Reports Fourth Quarter and Full Year 2024 Financial and Operational Results and Recent Business Updates -Today announced strategic collaboration with Hologen AI, including a $200 million 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 deve |
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| March 13, 2025 |
Exhibit 21 SUBSIDIARIES OF MEIRAGTX HOLDINGS PLC Legal Name of Subsidiary Jurisdiction of Organization BRI-Alzan, Inc. |
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| March 13, 2025 |
Exhibit 10.50 Certain information marked as [***] has been excluded from this exhibit because it is both not material and is the type that the registrant treats as private or confidential. FORM OF COLLABORATION AND LICENSE AGREEMENT by and among HOLOGEN NEURO AI LTD, HOLOGEN NEURO AI UK LIMITED, HOLOGEN LIMITED, MEIRAGTX HOLDINGS PLC, MEIRAGTX NEURO UK LIMITED and MEIRAGTX NEURO I, LLC , 2025 TABL |
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| March 13, 2025 |
Exhibit 99.1 MeiraGTx Enters into a Strategic Collaboration with Hologen AI to Expedite Phase 3 Development of AAV-GAD for Parkinson’s Disease and Industrialize MeiraGTx’s Proprietary Manufacturing Process -MeiraGTx to receive $200 million in upfront cash consideration -MeiraGTx and Hologen will form a joint venture, Hologen Neuro AI Ltd, with an additional $230 million committed capital from Holo |
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| March 13, 2025 |
Exhibit 107 CALCULATION OF FILING FEE TABLE FORM S-8 (Form Type) MEIRAGTX HOLDINGS PLC (Exact Name of Registrant as Specified in its Charter) Table I: Newly Registered Securities Plan Security Type Security Class Title Fee Calculation Rule Amount Registered(1) Proposed Maximum Offering Price Per Unit Maximum Aggregate Offering Price Fee Rate Amount of Registration Fee 2018 Incentive Award Plan Equity Ordinary Shares, nominal value $0. |
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| March 13, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K Current Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): March 9, 2025 MeiraGTx Holdings plc (Exact name of registrant as specified in its charter) Cayman Islands 001-38520 98-1448305 (State or other jurisdiction of incorporation or organiz |
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| March 13, 2025 |
Exhibit 10.49 EXECUTION VERSION Certain information marked as [***] has been excluded from this exhibit because it is both not material and is the type that the registrant treats as private or confidential. HOLOGEN NEURO AI LIMITED FRAMEWORK AGREEMENT Dated as of March 9, 2025 TABLE OF CONTENTS Page 1.DEFINITIONS. 7 2. INCORPORATION MATTERS. 15 2.1 Incorporation 15 2.2 Name 15 2.3 Registered Offic |
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| December 9, 2024 |
Exhibit 99.1 MeiraGTx Granted FDA Regenerative Medicine Advanced Therapy (RMAT) Designation for AAV2-hAQP1 for the Treatment of Grade 2/3 Radiation-Induced Xerostomia -RMAT designation recognizes the preliminary clinical evidence of the potential benefit of AAV2-hAQP1 as a one-time treatment for this debilitating condition -RMAT designation includes the benefits of the Fast Track and Breakthrough |
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| December 9, 2024 |
Financial Statements and Exhibits, Other Events UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K Current Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): December 9, 2024 MeiraGTx Holdings plc (Exact name of registrant as specified in its charter) Cayman Islands 001-38520 98-1448305 (State or other jurisdiction of incorporation or orga |
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| November 13, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q 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, 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 Numbe |
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| November 13, 2024 |
MeiraGTx Announces Third Quarter 2024 Financial and Operational Results and Recent Business Updates Exhibit 99.1 MeiraGTx Announces Third Quarter 2024 Financial and Operational Results and Recent Business Updates - Received 3 Rare Pediatric Disease Designations (RPDD) from FDA for each of 3 potential therapies for 3 different rare inherited retinopathies including AAV-AIPL1 - Agreed on pathway with MHRA for Marketing Authorization Application (MAA) under exceptional circumstances for AAV-AIPL1 f |
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| November 13, 2024 |
Financial Statements and Exhibits, Results of Operations and Financial Condition UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K Current Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): November 13, 2024 MeiraGTx Holdings plc (Exact name of registrant as specified in its charter) Cayman Islands 001-38520 98-1448305 (State or other jurisdiction of incorporation or org |
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| November 12, 2024 |
MGTX / MeiraGTx Holdings plc / Adage Capital Management, L.P. Passive Investment SC 13G/A 1 p24-3042sc13ga.htm SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G/A Under the Securities Exchange Act of 1934 (Amendment No. 4)*, ** MeiraGTx Holdings plc (Name of Issuer) Common Stock, par value $0.00003881 per share (Title of Class of Securities) G59665102 (CUSIP Number) September 30, 2024 (Date of Event Which Requires Filing of This Statement) Check the approp |
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| October 18, 2024 |
MGTX / MeiraGTx Holdings plc / JOHNSON & JOHNSON - SCHEDULE 13G/A Passive Investment SC 13G/A 1 s13g101524-meiragtx.htm SCHEDULE 13G/A SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G (Rule 13d-102) INFORMATION TO BE INCLUDED IN STATEMENTS FILED PURSUANT TO RULES 13d-1(b),(c) AND (d) AND AMENDMENTS THERETO FILED PURSUANT TO RULE 13d-2(b) (Amendment No. 2)1 MeiraGTx Holdings plc (Name of Issuer) Ordinary Shares, $.00003881 par value (Title of Class of Securiti |
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| October 15, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K Current Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): October 15, 2024 MeiraGTx Holdings plc (Exact name of registrant as specified in its charter) Cayman Islands 001-38520 98-1448305 (State or other jurisdiction of incorporation or orga |
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| October 15, 2024 |
Exhibit 99.1 MeiraGTx Announces Positive Data from Randomized, Sham-controlled Clinical Bridging Study of AAV-GAD for the Treatment of Parkinson’s Disease The primary study objective of safety and tolerability was met Significant and clinically meaningful improvements from baseline demonstrated for key efficacy endpoints at 26 weeks Significant improvement of 18 points in Unified Parkinson’s Disea |
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| August 14, 2024 |
MGTX / MeiraGTx Holdings plc / PERCEPTIVE ADVISORS LLC - SC 13D/A Activist Investment SC 13D/A SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13D/A Under the Securities Exchange Act of 1934 (Amendment No. 6)* MeiraGTx Holdings plc (Name of Issuer) Ordinary Shares, nominal value $0.00003881 per share (Title of Class of Securities) G59665 102 (CUSIP Number) Alexander Rakitin Perceptive Advisors LLC 51 Astor Place, 10th Floor New York, NY 10003 (646) 205-5340 (Name |
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| August 13, 2024 |
Underwriting Agreement, dated August 12, 2024, by and among the Company and BofA Securities, Inc. Exhibit 1.1 MeiraGTx Holdings plc (a Cayman Islands exempted company) 12,500,000 Ordinary Shares UNDERWRITING AGREEMENT Dated: August 12, 2024 MeiraGTx Holdings plc (a Cayman Islands exempted company) 12,500,000 ordinary shares, nominal value $0.00003881 per share UNDERWRITING AGREEMENT August 12, 2024 BofA Securities, Inc. as Representative of the several Underwriters c/o BofA Securities, Inc. On |
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| August 13, 2024 |
MGTX / MeiraGTx Holdings plc / Sanofi - SC 13G/A Passive Investment SC 13G/A UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G Under the Securities Exchange Act of 1934 (Amendment No. 1)* MeiraGTx Holdings plc (Name of Issuer) Ordinary Shares, $0.00003881 par value per share (Title of Class of Securities) G59665 102 (CUSIP Number) August 12, 2024 (Date of Event Which Requires Filing of this Statement) Check the appropriate box to |
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| August 13, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K Current Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): August 12, 2024 MeiraGTx Holdings plc (Exact name of registrant as specified in its charter) Cayman Islands 001-38520 98-1448305 (State or other jurisdiction of incorporation or organ |
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| August 12, 2024 |
TABLE OF CONTENTS Filed Pursuant to Rule 424(b)(5) Registration No. 333-276183 PROSPECTUS SUPPLEMENT (To Prospectus dated December 29, 2023) 12,500,000 Ordinary Shares We are offering 12,500,000 of our ordinary shares, nominal value $0.00003881 per ordinary share. Our ordinary shares are listed on the Nasdaq Global Select Market under the symbol “MGTX.” On August 9, 2024, the last reported sale |
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| August 12, 2024 |
Non-Employee Director Compensation Program. Exhibit 10.1 MEIRAGTX HOLDINGS PLC NON-EMPLOYEE DIRECTOR COMPENSATION PROGRAM (EFFECTIVE AS OF JUNE 6, 2024) Non-employee members of the board of directors (the “Board”) of MeiraGTx Holdings plc (the “Company”) shall receive cash and equity compensation as set forth in this Non-Employee Director Compensation Program (this “Program”). The cash and equity compensation described in this Program shall |
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| August 12, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q 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, 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: 00 |
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| August 12, 2024 |
Exhibit 99.1 MeiraGTx Announces $50 Million Offering of Ordinary Shares led by Sanofi and Reports Second Quarter 2024 Financial and Operational Results -Positive data from the Phase 1 AQUAx study in radiation-induced xerostomia (RIX) presented at the American Academy of Oral Medicine 2024 annual meeting (AAOM) showed meaningful improvements in patient-reported outcomes and saliva production with A |
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| August 12, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K Current Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): August 12, 2024 MeiraGTx Holdings plc (Exact name of registrant as specified in its charter) Cayman Islands 001-38520 98-1448305 (State or other jurisdiction of incorporation or organ |
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| June 10, 2024 |
Submission of Matters to a Vote of Security Holders UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K Current Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): June 6, 2024 MeiraGTx Holdings plc (Exact name of registrant as specified in its charter) Cayman Islands 001-38520 98-1448305 (State or other jurisdiction of incorporation or organiza |
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| May 9, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q 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: 0 |
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| May 9, 2024 |
Financial Statements and Exhibits, Results of Operations and Financial Condition UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K Current Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): May 9, 2024 MeiraGTx Holdings plc (Exact name of registrant as specified in its charter) Cayman Islands 001-38520 98-1448305 (State or other jurisdiction of incorporation or organizat |
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| May 9, 2024 |
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 bo |
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| April 25, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 (Amendment No. ) Filed by the Registrant ☒ Filed by a Party other than the Registrant ☐ Check the appropriate box: ☐ Preliminary Proxy Statement ☐ Confidential, for Use of the Commission Only (as permitted by Rule 14a-6(e)(2)) ☐ Defin |
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| April 25, 2024 |
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 (Amendment No. ) Filed by the Registrant ☒ Filed by a Party other than the Registrant ☐ Check the appropriate box: ☐ Preliminary Proxy Statement ☐ Confidential, for Use of the Commission Only (as permitted by Rule 14 |
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| April 16, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K/A (Amendment No. 1) Current Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): April 25, 2022 MeiraGTx Holdings plc (Exact name of registrant as specified in its charter) Cayman Islands 001-38520 98-1448305 (State or other jurisdiction of inc |
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| March 15, 2024 |
Exhibit 10.47 Certain information marked as [***] has been excluded from this exhibit because it is both not material and is the type that the registrant treats as private or confidential. ASSET PURCHASE AGREEMENT Dated as of December 20, 2023 by and among JANSSEN PHARMACEUTICALS, INC., MEIRAGTX UK II LIMITED and MEIRAGTX HOLDINGS PLC TABLE OF CONTENTS Page ARTICLE I DEFINITIONS; INTERPRETATION 1 |
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| March 15, 2024 |
Exhibit 10.39 CONSENT AND AMENDMENT This CONSENT AND AMENDMENT (this “Agreement”) is made and entered into as of December 20, 2023 by and among MEIRAGTX HOLDINGS PLC an exempted company with limited liability incorporated under the laws of the Cayman Islands with registration number 336306 (the “Issuer”), certain Subsidiaries (as defined in the Notes Purchase Agreement, defined below) of the Issue |
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| March 15, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K 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 MEIRAGT |
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| March 15, 2024 |
Exhibit 21 SUBSIDIARIES OF MEIRAGTX HOLDINGS PLC Legal Name of Subsidiary Jurisdiction of Organization BRI-Alzan, Inc. |
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| March 15, 2024 |
Policy for Recovery of Erroneously Awarded Compensation. Exhibit 97.1 MEIRAGTX HOLDINGS PLC POLICY FOR RECOVERY OF ERRONEOUSLY AWARDED COMPENSATION MeiraGTx Holdings plc (the “Company”) has adopted this Policy for Recovery of Erroneously Awarded Compensation (the “Policy”), effective as of October 2, 2023 (the “Effective Date”). Capitalized terms used in this Policy but not otherwise defined herein are defined in Section 11. 1. Persons Subject to Policy |
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| March 15, 2024 |
Exhibit 10.48 Certain information marked as [***] has been excluded from this exhibit because it is both not material and is the type that the registrant treats as private or confidential. TERMINATION AGREEMENT This Termination Agreement (this “Agreement”), dated as of December 20, 2023 (the “Effective Date”), is by and among Janssen Pharmaceuticals, Inc., a Delaware corporation (“Janssen”) on one |
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| March 14, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K Current Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): March 14, 2024 MeiraGTx Holdings plc (Exact name of registrant as specified in its charter) Cayman Islands 001-38520 98-1448305 (State or other jurisdiction of incorporation or organi |
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| March 14, 2024 |
Exhibit 99.1 MeiraGTx Reports Fourth Quarter and Full Year 2023 Financial and Operational Results and Recent Business Updates - Company aligned with FDA on requirements for ongoing Phase 2 AQUAx2 clinical trial for Grade 2/3 radiation-induced xerostomia to be considered pivotal supporting potential BLA filing - Company to present data from the Phase 1 AQUAx study in an oral presentation at the Ame |
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| February 14, 2024 |
MGTX / MeiraGTx Holdings plc / PERCEPTIVE ADVISORS LLC - SC 13D/A Activist Investment SC 13D/A SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13D/A Under the Securities Exchange Act of 1934 (Amendment No. 5)* MeiraGTx Holdings plc (Name of Issuer) Ordinary Shares, nominal value $0.00003881 per share (Title of Class of Securities) G59665 102 (CUSIP Number) Alexander Rakitin Perceptive Advisors LLC 51 Astor Place, 10th Floor New York, NY 10003 (646) 205-5340 (Name |
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| February 13, 2024 |
Exhibit 99.1 MeiraGTx Announces $50 Million Milestone from Janssen Pharmaceuticals -MeiraGTx to receive $50 million milestone after 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 (XLRP) LONDON and NEW YORK, February 13, 2024 (GLOBE NEWSWIRE) - MeiraGTx Holdings p |
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| February 13, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K Current Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): February 13, 2024 MeiraGTx Holdings plc (Exact name of registrant as specified in its charter) Cayman Islands 001-38520 98-1448305 (State or other jurisdiction of incorporation or org |
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| February 13, 2024 |
MGTX / MeiraGTx Holdings plc / Prosight Management, LP - SC 13G/A Passive Investment SC 13G/A UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G Under the Securities Exchange Act of 1934 (Amendment No. 1)* MEIRAGTX HOLDINGS PLC (Name of Issuer) Ordinary Shares, $0.00003881 par value per share (Title of Class of Securities) G59665102 (CUSIP Number) December 31, 2023 (Date of Event which Requires Filing of this Statement) Check the appropriate box t |
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| February 7, 2024 |
SC 13G/A 1 p24-0383sc13ga.htm MEIRAGTX HOLDINGS PLC SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G/A Under the Securities Exchange Act of 1934 (Amendment No. 3)* MeiraGTx Holdings plc (Name of Issuer) Common Stock, par value $0.00003881 per share (Title of Class of Securities) G59665102 (CUSIP Number) December 31, 2023 (Date of Event Which Requires Filing of This Statement) |
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| December 27, 2023 |
MeiraGTx Holdings plc 450 East 29th Street, 14th Floor New York, New York 10016 MeiraGTx Holdings plc 450 East 29th Street, 14th Floor New York, New York 10016 December 27, 2023 Via EDGAR Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, N. |
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| December 21, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K Current Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): December 20, 2023 MeiraGTx Holdings plc (Exact name of registrant as specified in its charter) Cayman Islands 001-38520 98-1448305 (State or other jurisdiction of incorporation or org |
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| December 21, 2023 |
Exhibit 99.1 MeiraGTx Announces Asset Purchase Agreement Involving its AAV-RPGR Collaboration for up to $415 million - MeiraGTx enters into an Asset Purchase Agreement related to botaretigene sparoparvovec (bota-vec, formerly AAV-RPGR) for the treatment of X-linked retinitis pigmentosa (XLRP) for a total of up to $415 million - MeiraGTx to receive $130 million in upfront and near-term milestone pa |
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| December 21, 2023 |
Exhibit 1.2 MEIRAGTX HOLDINGS PLC Ordinary Shares (nominal value $0.00003881 per share) Sales Agreement December 21, 2023 BofA Securities, Inc. One Bryant Park New York, NY 10036 Ladies and Gentlemen: MeiraGTx Holdings plc, a Cayman Islands exempted company (the “Company”), confirms its agreement (this “Agreement”) with BofA Securities, Inc. (the “Agent”), as follows: 1. Issuance and Sale of Place |
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| December 21, 2023 |
As filed with the Securities and Exchange Commission on December 21, 2023 TABLE OF CONTENTS As filed with the Securities and Exchange Commission on December 21, 2023 Registration No. |
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| December 21, 2023 |
Exhibit 107 Calculation of Filing Fee Tables Form S-3 (Form Type) MeiraGTx Holdings Plc (Exact Name of Registrant as Specified in its Charter) Table 1: Newly Registered and Carry Forward Securities CALCULATION OF REGISTRATION FEE Security Type Security Class Title Fee Calculation Rule Amount Registered Proposed Maximum Offering Price Per Unit(1) Maximum Aggregate Offering Price(1)(4) Fee Rate Amount of Registration Fee Carry Forward Form Type Carry Forward File Number Carry Forward Initial Effective Date Filing Fee Previously Paid In Connection with Unsold Securities to be Carried Forward Newly Registered Securities Fees to Be Paid Equity Ordinary shares, nominal value $0. |
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| November 14, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q 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 Numbe |
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| November 14, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K Current Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): November 14, 2023 MeiraGTx Holdings plc (Exact name of registrant as specified in its charter) Cayman Islands 001-38520 98-1448305 (State or other jurisdiction of incorporation or org |
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| November 14, 2023 |
Exhibit 99.1 MeiraGTx Announces Third Quarter 2023 Financial and Operational Results - Received strategic investment from Sanofi purchasing $30 million of ordinary shares of the Company at a price of $7.50 per share in October 2023 -Announced a right of first negotiation (ROFN) with Sanofi for the use of MeiraGTx’s Riboswitch gene regulation technology for certain Central Nervous System (CNS) and |
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| November 6, 2023 |
MGTX / MeiraGTx Holdings plc / Sanofi - SC 13G Passive Investment SC 13G 1 d866699dsc13g.htm SC 13G UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G Under the Securities Exchange Act of 1934 MeiraGTx Holdings plc (Name of Issuer) Ordinary Shares, $0.00003881 par value per share (Title of Class of Securities) G59665 102 (CUSIP Number) October 30, 2023 (Date of Event Which Requires Filing of this Statement) Check the appropriate |
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| October 30, 2023 |
Exhibit 10.1 EXECUTION VERSION INVESTMENT AGREEMENT This INVESTMENT AGREEMENT (this “Agreement”) is made and entered into as of October 30, 2023 by and between MeiraGTx Holdings plc, a Cayman Islands exempted company (the “Company”), Sanofi Foreign Participations B.V., a company incorporated in the Netherlands whose registered office is at Paasheuvelweg 25, 1105 BP Amsterdam, Netherlands (the “Inv |
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| October 30, 2023 |
Exhibit 10.2 EXECUTION VERSION REGISTRATION RIGHTS AGREEMENT This REGISTRATION RIGHTS AGREEMENT (this “Agreement”) is made and entered into as of October 30, 2023 by and between MeiraGTx Holdings plc, a Cayman Islands exempted company (the “Company”), and Sanofi Foreign Participations B.V., a company incorporated in the Netherlands whose registered office is at Paasheuvelweg 25, 1105 BP Amsterdam, |
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| October 30, 2023 |
Exhibit 99.1 MeiraGTx Announces $30 Million Strategic Investment from Sanofi; Company Pursuing Multiple Additional Strategic Opportunities - Sanofi to purchase $30 million of ordinary shares of the Company at a price of $7.50 per share - Sanofi to receive a right of first negotiation (ROFN) for the use of MeiraGTx’s Riboswitch gene regulation technology for certain Immunology and Inflammation (I&I |
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| October 30, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K Current Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): October 30, 2023 MeiraGTx Holdings plc (Exact name of registrant as specified in its charter) Cayman Islands 001-38520 98-1448305 (State or other jurisdiction of incorporation or orga |
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| August 10, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K Current Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): August 10, 2023 MeiraGTx Holdings plc (Exact name of registrant as specified in its charter) Cayman Islands 001-38520 98-1448305 (State or other jurisdiction of incorporation or organ |
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| August 10, 2023 |
Exhibit 10.1 Execution Version CONSENT AND AMENDMENT TO AMENDED AND RESTATED NOTE PURCHASE AGREEMENT AND GUARANTY This CONSENT AND AMENDMENT TO AMENDED AND RESTATED NOTE PURCHASE AGREEMENT AND GUARANTY, dated as of August 10, 2023 (this “Agreement”), is by and among MEIRAGTX HOLDINGS PLC, an exempted company with limited liability incorporated under the laws of the Cayman Islands with registration |
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| August 10, 2023 |
Non-Employee Director Compensation Program. Exhibit 10.4 MEIRAGTX HOLDINGS PLC NON-EMPLOYEE DIRECTOR COMPENSATION PROGRAM (EFFECTIVE AS OF JUNE 5, 2023) Non-employee members of the board of directors (the “Board”) of MeiraGTx Holdings plc (the “Company”) shall receive cash and equity compensation as set forth in this Non-Employee Director Compensation Program (this “Program”). The cash and equity compensation described in this Program shall |
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| August 10, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q 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: 00 |
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| August 10, 2023 |
Exhibit 10.3 FIRST AMENDMENT TO REGISTRATION RIGHTS AGREEMENT OF MEIRAGTX HOLDINGS PLC THIS FIRST AMENDMENT to the Registration Rights Agreement (this “Amendment”), dated as of May 12, 2023, is entered into by and among MeiraGTx Holdings plc, a Cayman Islands exempted company (the “Company”) and Johnson & Johnson Innovation – JJDC, Inc. (the “Investor” and, together with the Company, the “Parties” |
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| August 10, 2023 |
MeiraGTx Reports Second Quarter 2023 Financial and Operational Results Exhibit 99.1 MeiraGTx Reports Second Quarter 2023 Financial and Operational Results - Phase 3 LUMEOS clinical trial of botaretigene sparoparvovec (bota-vec, formerly AAV-RPGR) for the treatment of X-linked retinitis pigmentosa (XLRP) enrollment target has now been surpassed - Announced positive clinical data from the completed AQUAx Phase 1 study of AAV2-hAQP1 for the treatment of grade 2/3 radiat |
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| August 9, 2023 |
MeiraGTx Holdings plc 450 East 29th Street, 14th Floor New York, New York 10016 MeiraGTx Holdings plc 450 East 29th Street, 14th Floor New York, New York 10016 August 9, 2023 Via EDGAR Securities and Exchange Commission Division of Corporation Finance Office of Finance 100 F Street, N. |
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| August 9, 2023 |
MeiraGTx Holdings plc 450 East 29th Street, 14th Floor New York, New York 10016 MeiraGTx Holdings plc 450 East 29th Street, 14th Floor New York, New York 10016 August 9, 2023 Via EDGAR Securities and Exchange Commission Division of Corporation Finance Office of Finance 100 F Street, N. |
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| August 3, 2023 |
Exhibit 10.2 Execution Version REGISTRATION RIGHTS AGREEMENT This REGISTRATION RIGHTS AGREEMENT (this “Agreement”) is made and entered into as of May 5, 2023 by and among MeiraGTx Holdings plc, a Cayman Islands exempted company (the “Company”), and each investor party to that certain Securities Purchase Agreement (the “Purchase Agreement”), by and among the Company and each such investor (each an |
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| August 3, 2023 |
Calculation of Filing Fee Table. Exhibit 107 Calculation of Filing Fee Tables Form S-3 (Form Type) MeiraGTx Holdings Plc (Exact Name of Registrant as Specified in its Charter) Table 1: Newly Registered and Carry Forward Securities CALCULATION OF REGISTRATION FEE Security Type Security Class Title Fee Calculation Rule Amount Registered Proposed Maximum Offering Price Per Unit Maximum Aggregate Offering Price Fee Rate Amount of Registration Fee Carry Forward Form Type Carry Forward File Number Carry Forward Initial Effective Date Filing Fee Previously Paid In Connection with Unsold Securities to be Carried Forward Newly Registered Securities Fees to Be Paid Equity Ordinary shares 457(c) 3,742,514 (1)(2) $6. |
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| August 3, 2023 |
Calculation of Filing Fee Table. Exhibit 107 Calculation of Filing Fee Tables Form S-3 (Form Type) MeiraGTx Holdings Plc (Exact Name of Registrant as Specified in its Charter) Table 1: Newly Registered and Carry Forward Securities CALCULATION OF REGISTRATION FEE Security Type Security Class Title Fee Calculation Rule Amount Registered Proposed Maximum Offering Price Per Unit Maximum Aggregate Offering Price Fee Rate Amount of Registration Fee Carry Forward Form Type Carry Forward File Number Carry Forward Initial Effective Date Filing Fee Previously Paid In Connection with Unsold Securities to be Carried Forward Newly Registered Securities Fees to Be Paid Equity Ordinary shares 457(c) 9,144,801 (1)(2) $6. |
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| August 3, 2023 |
Exhibit 10.1 Certain information marked as [***] has been excluded from this exhibit because it is both not material and is the type that the registrant treats as private or confidential. Execution Version SECURITIES PURCHASE AGREEMENT This SECURITIES PURCHASE AGREEMENT (this “Agreement”) is made and entered into as of May 3, 2023 by and among MeiraGTx Holdings plc, a Cayman Islands exempted compa |
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| August 3, 2023 |
As filed with the Securities and Exchange Commission on August 3, 2023 TABLE OF CONTENTS As filed with the Securities and Exchange Commission on August 3, 2023 Registration No. |
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| August 3, 2023 |
As filed with the Securities and Exchange Commission on August 3, 2023 TABLE OF CONTENTS As filed with the Securities and Exchange Commission on August 3, 2023 Registration No. |
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| June 12, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K Current Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): June 8, 2023 MeiraGTx Holdings plc (Exact name of registrant as specified in its charter) Cayman Islands 001-38520 98-1448305 (State or other jurisdiction of incorporation or organiza |
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| May 16, 2023 |
MGTX / MeiraGTx Holdings plc / PERCEPTIVE ADVISORS LLC - SC 13D/A Activist Investment SC 13D/A SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13D/A Under the Securities Exchange Act of 1934 (Amendment No. 4)* MeiraGTx Holdings plc (Name of Issuer) Ordinary Shares, nominal value $0.00003881 per share (Title of Class of Securities) G59665 102 (CUSIP Number) Alexander Rakitin Perceptive Advisors LLC 51 Astor Place, 10th Floor New York, NY 10003 (646) 205-5340 (Name |
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| May 15, 2023 |
JOINT FILING AGREEMENT May 12, 2023 EX-99.1 Exhibit 99.1 JOINT FILING AGREEMENT May 12, 2023 Pursuant to and in accordance with the Securities Exchange Act of 1934, as amended (the “Act”), and the rules and regulations thereunder, each party hereto hereby agrees to the joint filing, on behalf of each of them, of any filing required by such party under Section 13 or Section 16 of the Act or any rule or regulation thereunder (includin |
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| May 15, 2023 |
MGTX / MeiraGTx Holdings plc / Prosight Management, LP - SC 13G Passive Investment SC 13G UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G Under the Securities Exchange Act of 1934 (Amendment No. )* MEIRAGTX HOLDINGS PLC (Name of Issuer) Ordinary Shares, $0.00003881 par value per share (Title of Class of Securities) G59665102 (CUSIP Number) May 5, 2023 (Date of Event which Requires Filing of this Statement) Check the appropriate box to designa |
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| May 11, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K Current Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): May 11, 2023 MeiraGTx Holdings plc (Exact name of registrant as specified in its charter) Cayman Islands 001-38520 98-1448305 (State or other jurisdiction of incorporation or organiza |
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| May 11, 2023 |
MeiraGTx Reports First Quarter 2023 Financial and Operational Results Exhibit 99.1 MeiraGTx Reports First Quarter 2023 Financial and Operational Results - Raised approximately $60 million in a private placement in May 2023 with investors consisting of several of the Company’s top shareholders - On track for BLA submission of botaretigene sparoparvovec (bota-vec, formerly AAV-RPGR) for the treatment of X-linked retinitis pigmentosa (XLRP) in 2024 - Company will prese |
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| May 11, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q 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 |
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| May 9, 2023 |
Entry into a Material Definitive Agreement, Unregistered Sales of Equity Securities UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K Current Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): May 3, 2023 MeiraGTx Holdings plc (Exact name of registrant as specified in its charter) Cayman Islands 001-38520 98-1448305 (State or other jurisdiction of incorporation or organizat |
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| April 27, 2023 |
Definitive Proxy Statement on Schedule 14A, filed with the SEC on April 27, 2023 Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 (Amendment No. ) Filed by the Registrant ☒ Filed by a Party other than the Registrant ☐ Check the appropriate box: ☐ Preliminary Proxy Statement ☐ Confidential, for Use of the Commission Only (as permitted by Rule 14 |
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| April 27, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 (Amendment No. ) Filed by the Registrant ☒ Filed by a Party other than the Registrant ☐ Check the appropriate box: ☐ Preliminary Proxy Statement ☐ Confidential, for Use of the Commission Only (as permitted by Rule 14a-6(e)(2)) ☐ Defin |
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| April 26, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K Current Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): April 21, 2023 MeiraGTx Holdings plc (Exact name of registrant as specified in its charter) Cayman Islands 001-38520 98-1448305 (State or other jurisdiction of incorporation or organi |
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| April 24, 2023 |
Robert J. Wollin – General Counsel and Secretary [email protected] April 24, 2023 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, NE Washington, DC 20549 Attn:Vanessa Robertson Kevin Vaughn Re: MeiraGTx Holdings plc Form 10-K for the fiscal year ended December 31, 2022 Filed March 14, 2023 File No. 001-38520 To the ad |
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| March 14, 2023 |
Exhibit 10.39 SECURITIES PURCHASE AGREEMENT This SECURITIES PURCHASE AGREEMENT (this “Agreement”) is made and entered into as of November 9, 2022 by and among MeiraGTx Holdings plc, a Cayman Islands exempted company (the “Company”), and Johnson & Johnson Innovation – JJDC, Inc. (the “Investor”). RECITALS A.The Company and the Investor are executing and delivering this Agreement in reliance upon th |
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| March 14, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K Current Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): March 14, 2023 MeiraGTx Holdings plc (Exact name of registrant as specified in its charter) Cayman Islands 001-38520 98-1448305 (State or other jurisdiction of incorporation or organi |
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| March 14, 2023 |
Exhibit 10.36 AMENDMENT NO. 1 TO CREDIT AGREEMENT AND GUARANTY This AMENDMENT NO. 1 TO CREDIT AGREEMENT AND GUARANTY, dated as of December 19, 2022 (this “Amendment”), is by and among MEIRAGTX HOLDINGS PLC, an exempted company with limited liability incorporated under the laws of the Cayman Islands with registration number 336306 (the “Borrower”), certain Subsidiaries of the Borrower party hereto |
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| March 14, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K 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, 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 MEIRAGT |
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| March 14, 2023 |
Exhibit 10.40 REGISTRATION RIGHTS AGREEMENT This REGISTRATION RIGHTS AGREEMENT (this “Agreement”) is made and entered into as of November 9, 2022 by and among MeiraGTx Holdings plc, a Cayman Islands exempted company (the “Company”), and Johnson & Johnson Innovation – JJDC, Inc. (the “Investor”) in connection with that certain Securities Purchase Agreement by and among the Company and the Investor |
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| March 14, 2023 |
Exhibit 10.38 NOTE December 19, 2022 U.S. $75,000,000 FOR VALUE RECEIVED, the undersigned, MeiraGTx Holdings plc, an exempted company incorporated under the laws of the Cayman Islands with registration number 336306 (the “Issuer”), hereby promises to pay to Perceptive Credit Holdings III, LP (the “Noteholder”), in immediately available funds, the aggregate principal sum set forth above, or, if les |
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| March 14, 2023 |
Exhibit 21 SUBSIDIARIES OF MEIRAGTX HOLDINGS PLC Legal Name of Subsidiary Jurisdiction of Organization BRI-Alzan, Inc. |
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| March 14, 2023 |
Exhibit 10.37 Certain information marked as [***] has been excluded from this exhibit because it is both not material and is the type that the registrant treats as private or confidential. AMENDED AND RESTATED NOTES PURCHASE AGREEMENT AND GUARANTY dated as of August 2, 2022 as amended and restated as of December 19, 2022 by and among MEIRAGTX HOLDINGS PLC, as the Issuer THE SUBSIDIARY GUARANTORS F |
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| March 14, 2023 |
Exhibit 99.1 MeiraGTx Reports Fourth Quarter and Full Year 2022 Financial and Operational Results -Announced positive clinical data from AQUAx AAV-hAQP1 Phase 1 trial for treatment of Grade 2/3 Radiation-Induced Xerostomia in December 2022 -Announced positive top-line data from the MGT009 Phase 1/2 clinical study demonstrating safety and improvement in multiple domains of vision in X-linked retini |
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| March 10, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K Current Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): March 10, 2023 MeiraGTx Holdings plc (Exact name of registrant as specified in its charter) Cayman Islands 001-38520 98-1448305 (State or other jurisdiction of incorporation or organi |
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| February 14, 2023 |
EX-99 2 ss1758589ex99a.htm JOINT FILING AGREEMENT EXHIBIT A JOINT FILING AGREEMENT The undersigned hereby agree that the Statement on this Schedule 13G dated December 31, 2022 (the “Schedule 13G”), with respect to the Ordinary Shares, per value of $0.00003881 per share, of MeiraGTx Holdings plc is filed on behalf of each of us pursuant to and in accordance with the provisions of Rule 13d-1(k) unde |
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| February 14, 2023 |
MGTX / MeiraGTx Holdings PLC / ORBIMED ADVISORS LLC - AMENDMENT NO. 3 Passive Investment SC 13G/A 1 ss1758589sc13ga.htm AMENDMENT NO. 3 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 SCHEDULE 13G (Amendment No. 3)* Under the Securities Exchange Act of 1934 MeiraGTx Holdings plc (Name of Issuer) Ordinary Shares, $0.00003881 par value per share (Title of Class of Securities) G59665102 (CUSIP Number) December 31, 2022 (Date of Event Which Requires Filing of this St |
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| February 9, 2023 |
SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G/A Under the Securities Exchange Act of 1934 (Amendment No. 2)* MeiraGTx Holdings plc (Name of Issuer) Ordinary Shares, par value $0.00003881 per share (Title of Class of Securities) G59665102 (CUSIP Number) December 31, 2022 (Date of Event Which Requires Filing of This Statement) Check the appropriate box to designate the rule |
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| January 20, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 (Amendment No. ) Filed by the Registrant ☒ Filed by a Party other than the Registrant ☐ Check the appropriate box: ☐ Preliminary Proxy Statement ☐ Confidential, for Use of the Commission Only (as permitted by Rule 14a-6(e)(2)) ☐ Defin |
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| December 23, 2022 |
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 (Amendment No. ) Filed by the Registrant ☒ Filed by a party other than the Registrant ☐ Check the appropriate box: ☐ Preliminary Proxy Statement ☐ Confidential, for Use of the Commission Only (as permitted by Rule 14 |
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| November 14, 2022 |
MGTX / MeiraGTx Holdings PLC / JOHNSON & JOHNSON - SC 13G/A Passive Investment SC 13G/A CUSIP No. G59665102 SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G (Rule 13d-102) INFORMATION TO BE INCLUDED IN STATEMENTS FILED PURSUANT TO RULES 13d-1(b),(c) AND (d) AND AMENDMENTS THERETO FILED PURSUANT TO RULE 13d-2(b) (Amendment No. 1)1 MeiraGTx Holdings plc (Name of Issuer) Ordinary Shares, $.00003881 par value (Title of Class of Securities) G59665102 (CUSIP |
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| November 10, 2022 |
Exhibit 4.1 SCHEDULE OF WARRANT HOLDERS In accordance with Instruction 2 to Item 601 of Regulation S-K, below is a schedule setting forth details in which the omitted executed warrants differ from the form of warrant that follows: Holder Exercise Price Per Share Number of Ordinary Shares Perceptive Credit Holdings III, LP $15.00 400,000 Perceptive Credit Holdings III, LP $20.00 300,000 Total 700,0 |
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| November 10, 2022 |
Exhibit 99.1 MeiraGTx Reports Third Quarter 2022 Financial and Operational Results and Receives $25 Million Investment from Johnson & Johnson Innovation - JJDC, Inc. - Updated Positive Topline Data from the Phase 1/2 Trial of Botaretigene Sparoparvovec (AAV-RPGR) for the Treatment of X-linked Retinitis Pigmentosa (XLRP) - Now Dosing Patients in Phase 1 Trial Evaluating AAV-GAD Gene Therapy for Par |
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| November 10, 2022 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q 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, 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 Meira |
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| November 10, 2022 |
Exhibit 10.1 Certain information marked as [***] has been excluded from this exhibit because it is both not material and is the type that the registrant treats as private or confidential. CREDIT AGREEMENT AND GUARANTY dated as of August 2, 2022 by and among MEIRAGTX HOLDINGS PLC, as the Borrower, THE SUBSIDIARY GUARANTORS FROM TIME TO TIME PARTY HERETO, as the Subsidiary Guarantors, THE LENDERS FR |
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| November 10, 2022 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K Current Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): November 9, 2022 MeiraGTx Holdings plc (Exact name of registrant as specified in its charter) Cayman Islands 001-38520 98-1448305 (State or other jurisdiction of incorporation or orga |
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| August 11, 2022 |
Exhibit 99.1 ? ? MeiraGTx Reports Second Quarter 2022 Financial and Operational Results ? - Recent Positive Topline Data from the Phase 1/2 Trial of Botaretigene Sparoparvovec (AAV-RPGR) for the Treatment of X-linked Retinitis Pigmentosa (XLRP) ? - Financing Secured by Manufacturing Facilities Extends Cash Runway to Fourth Quarter 2024 ? LONDON and NEW YORK, August 11, 2022 (GLOBE NEWSWIRE) - Meir |
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| August 11, 2022 |
Financial Statements and Exhibits, Results of Operations and Financial Condition ? ? UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K Current Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): August 11, 2022 MeiraGTx Holdings plc (Exact name of registrant as specified in its charter) ? ? ? ? ? ? Cayman Islands 001-38520 98-1448305 (State or other jurisdiction of incorp |
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| August 11, 2022 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q ? ? 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, 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 MeiraG |
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| August 4, 2022 |
Exhibit 99.1 ? MeiraGTx Announces Financing Agreement with Perceptive Advisors for Up to $100 Million Secured by Manufacturing Facilities ? - Credit facility is collateralized by MeiraGTx?s wholly-owned manufacturing facilities in London, UK and Shannon, Ireland - $75 million at closing strengthens balance sheet and extends runway to fourth quarter of 2024 ? LONDON and NEW YORK, August 3, 2022 (GL |
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| August 4, 2022 |
? ? UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K Current Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): August 2, 2022 MeiraGTx Holdings plc (Exact name of registrant as specified in its charter) ? ? ? ? ? ? Cayman Islands 001-38520 98-1448305 (State or other jurisdiction of incorpo |
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| June 27, 2022 |
? ? UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K Current Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): June 27, 2022 MeiraGTx Holdings plc (Exact name of registrant as specified in its charter) ? ? ? ? ? ? Cayman Islands 001-38520 98-1448305 (State or other jurisdiction of incorpor |
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| June 9, 2022 |
Submission of Matters to a Vote of Security Holders ? ? UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K Current Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): June 7, 2022 MeiraGTx Holdings plc (Exact name of registrant as specified in its charter) ? ? ? ? ? ? Cayman Islands 001-38520 98-1448305 (State or other jurisdiction of incorpora |
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| May 12, 2022 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q ? ? 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, 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 Meira |
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| May 12, 2022 |
Financial Statements and Exhibits, Results of Operations and Financial Condition ? ? UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K Current Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): May 12, 2022 MeiraGTx Holdings plc (Exact name of registrant as specified in its charter) ? ? ? ? ? ? Cayman Islands 001-38520 98-1448305 (State or other jurisdiction of incorpora |
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| May 12, 2022 |
Exhibit 99.1 ? MeiraGTx Reports First Quarter 2022 Financial and Operational Results -Phase 3 Lumeos Clinical Trial of Botaretigene Sparoparvovec (AAV-RPGR) for the Treatment of X-linked Retinitis Pigmentosa (XLRP) Actively Dosing Patients -Phase 1 AQUAx Study of AAV-hAQP1 for Radiation-Induced Xerostomia Completed Dosing of Both Unilateral and Bilateral Cohorts in the First Quarter of 2022 LONDON |
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| May 2, 2022 |
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 (Amendment No. ) ? ? ? Filed by the Registrant ? Filed by a Party other than the Registrant ? Check the appropriate box: ? Preliminary Proxy Statement ? Confidential, for Use of the Commission Only (as permitted by R |
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| April 27, 2022 |
MeiraGTx Appoints Debra Yu, MD to Board of Directors Exhibit 99.1 ? ? MeiraGTx Appoints Debra Yu, MD to Board of Directors ? LONDON and NEW YORK, April 27, 2022 (GLOBE NEWSWIRE) - MeiraGTx Holdings plc (NASDAQ:MGTX), a vertically integrated, clinical stage gene therapy company, today announced the appointment of Dr. Debra Yu to its Board of Directors. Dr. Yu currently serves as President and Chief Strategy Officer of LianBio, and previously served a |
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| April 27, 2022 |
? ? UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K Current Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): April 25, 2022 MeiraGTx Holdings plc (Exact name of registrant as specified in its charter) ? ? ? ? ? ? Cayman Islands 001-38520 98-1448305 (State or other jurisdiction of incorpo |
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| March 10, 2022 |
Exhibit 10.36 MEIRAGTX HOLDINGS PLC 2018 INCENTIVE AWARD PLAN RESTRICTED SHARE UNIT GRANT NOTICE Capitalized terms not specifically defined in this Restricted Share Unit Grant Notice (the ?Grant Notice?) have the meanings given to them in the 2018 Incentive Award Plan (as amended from time to time, the ?Plan?) of MeiraGTx Holdings plc (the ?Company?). The Company has granted to the participant lis |
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| March 10, 2022 |
Exhibit 21 ? SUBSIDIARIES OF MEIRAGTX HOLDINGS PLC ? ? Legal Name of Subsidiary Jurisdiction of Organization BRI-Alzan, Inc. |
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| March 10, 2022 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K Table of Contents ? ? UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D. |
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| March 10, 2022 |
Financial Statements and Exhibits, Results of Operations and Financial Condition ? ? UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K Current Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): March 10, 2022 MeiraGTx Holdings plc (Exact name of registrant as specified in its charter) ? ? ? ? ? ? Cayman Islands 001-38520 98-1448305 (State or other jurisdiction of incorpo |
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| March 10, 2022 |
Exhibit 99.1 ? MeiraGTx Reports Fourth Quarter and Full Year 2021 Financial and Operational Results ? - Phase 3 Lumeos Clinical Trial of botaretigene sparoparvovec (AAV-RPGR) for the Treatment of X-linked Retinitis Pigmentosa (XLRP) Enrolling and Dosing Patients - Received $30 Million Cash Milestone Payment from Janssen Pharmaceuticals, Inc. - Positive Preliminary Clinical Data from AQUAx AAV-hAQP |
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| March 10, 2022 |
First Amendment to Collaboration, Option and License Agreement, dated December 16, 2021. Exhibit 10.26 Certain information marked as [***] has been excluded from this exhibit because it is both (i) not material and (ii) is the type that the Company treats as private or confidential. FIRST AMENDMENT TO COLLABORATION, OPTION AND LICENSE AGREEMENT This First Amendment (the ?Amendment?) is entered into by and among Janssen Pharmaceuticals, Inc. (?Janssen?), MeiraGTx UK II Limited and Meir |
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| March 10, 2022 |
Deferred Compensation Plan for Non-Employee Directors. Exhibit 10.35 MEIRAGTX HOLDINGS PLC DEFERRED COMPENSATION PLAN FOR NON-EMPLOYEE DIRECTORS 1.Purpose and Effective Date. The purpose of the Plan is to provide the non-employee members of the Board of Directors (the ?Board?) of MeiraGTx Holdings plc (the ?Company?), with an opportunity to defer payment of all or a portion of their Restricted Share Units. The Plan shall be effective as of December 17 |
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| February 11, 2022 |
MGTX / MeiraGTx Holdings PLC / ORBIMED ADVISORS LLC - AMENDMENT NO. 2 Passive Investment UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 SCHEDULE 13G (Amendment No. |
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| February 11, 2022 |
CUSIP No. G59665102 SCHEDULE 13G Page 8 of 8 Pages EXHIBIT A JOINT FILING AGREEMENT The undersigned hereby agree that the Statement on this Schedule 13G dated February 11, 2022 (the ?Schedule 13G?), with respect to the Ordinary Shares, per value of $0.00003881 per share, of MeiraGTx Holdings plc is filed on behalf of each of us pursuant to and in accordance with the provisions of Rule 13d-1(k) und |
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| February 11, 2022 |
MGTX / MeiraGTx Holdings PLC / ALEXANDRIA REAL ESTATE EQUITIES, INC. - SC 13G/A Passive Investment UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G (Amendment No. 1) Under the Securities Exchange Act of 1934 MeiraGTx Holdings plc (Name of Issuer) Ordinary Shares, $0.00003881 par value per share (Title of Class of Securities) G59665 102 (CUSIP Number) December 31, 2021 (Date of Event Which Requires Filing of This Statement) Check the appropriate box to designa |
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| February 10, 2022 |
MGTX / MeiraGTx Holdings PLC / ADAGE CAPITAL PARTNERS GP, L.L.C. Passive Investment SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G/A Under the Securities Exchange Act of 1934 (Amendment No. 1)* MeiraGTx Holdings plc (Name of Issuer) Ordinary Shares, par value $0.00003881 per share (Title of Class of Securities) G59665102 (CUSIP Number) December 31, 2021 (Date of Event Which Requires Filing of This Statement) Check the appropriate box to designate the rule |
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| December 7, 2021 |
? ? Exhibit 99.1 MeiraGTx Announces Positive Preliminary Data from the AQUAx Phase 1 Clinical Trial of AAV-hAQP1 for the Treatment of Grade 2/3 Radiation-Induced Xerostomia ? Clinically meaningful improvements in xerostomia symptoms and disease burden reported in two validated Patient Reported Outcome (PRO) measures ? 6 of the 7 participants through 90-day assessments following treatment achieved |
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| December 7, 2021 |
Exhibit 99.2 CONFIDENTIAL Gene Therapy for the Treatment of Radiation-Induced Xerostomia: AAV-hAQP1 Program Update December 7, 2021 CONFIDENTIAL 2 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 |
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| December 7, 2021 |
Regulation FD Disclosure, Financial Statements and Exhibits ? ? UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K Current Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): December 7, 2021 MeiraGTx Holdings plc (Exact name of registrant as specified in its charter) ? ? ? ? ? ? Cayman Islands 001-38520 98-1448305 (State or other jurisdiction of incor |
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| November 10, 2021 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q ? ? 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, 2021 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 M |
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| November 10, 2021 |
Financial Statements and Exhibits, Results of Operations and Financial Condition ? ? UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K Current Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): November 10, 2021 MeiraGTx Holdings plc (Exact name of registrant as specified in its charter) ? ? ? ? ? ? Cayman Islands 001-38520 98-1448305 (State or other jurisdiction of inco |
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| November 10, 2021 |
MeiraGTx Reports Third Quarter 2021 Financial and Operational Results ? ? Exhibit 99.1 MeiraGTx Reports Third Quarter 2021 Financial and Operational Results ? LONDON and NEW YORK, November 10, 2021 (GLOBE NEWSWIRE) - MeiraGTx Holdings plc (Nasdaq: MGTX), a vertically integrated, clinical stage gene therapy company, today announced financial results for the third quarter ended September 30, 2021 and provided an update on recent progress. During the quarter, MeiraGTx |
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| November 4, 2021 |
SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G Under the Securities Exchange Act of 1934 (Amendment No. )* MeiraGTx Holdings plc (Name of Issuer) Ordinary Shares, par value $0.00003881 per share (Title of Class of Securities) G59665102 (CUSIP Number) October 25, 2021 (Date of Event Which Requires Filing of This Statement) Check the appropriate box to designate the rule purs |
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| August 11, 2021 |
Non-Employee Director Compensation Program. Exhibit 10.1 ? MeiraGTx Holdings plc ? Non-Employee Director Compensation Program (effective as of June 7, 2021) ? Non-employee members of the board of directors (the ?Board?) of MeiraGTx Holdings plc (the ?Company?) shall receive cash and equity compensation as set forth in this Non-Employee Director Compensation Program (this ?Program?). The cash and equity compensation described in this Program |
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| August 11, 2021 |
MeiraGTx Reports Second Quarter 2021 Financial and Operational Results Exhibit 99.1 ? ? MeiraGTx Reports Second Quarter 2021 Financial and Operational Results ? LONDON and NEW YORK, August 11, 2021 (GLOBE NEWSWIRE) - MeiraGTx Holdings plc (Nasdaq: MGTX), a vertically integrated, clinical stage gene therapy company, today announced financial results for the second quarter ended June 30, 2021 and provided an update on recent progress. ? ?As we move into the second half |
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| August 11, 2021 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q ? ? 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, 2021 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 MeiraG |
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| August 11, 2021 |
Financial Statements and Exhibits, Results of Operations and Financial Condition ? ? UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K Current Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): August 11, 2021 MeiraGTx Holdings plc (Exact name of registrant as specified in its charter) ? ? ? ? ? ? Cayman Islands 001-38520 98-1448305 (State or other jurisdiction of incorp |
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| June 17, 2021 |
As filed with the Securities and Exchange Commission on June 17, 2021 ? ? As filed with the Securities and Exchange Commission on June 17, 2021 Registration No. |
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| June 11, 2021 |
Submission of Matters to a Vote of Security Holders ? ? UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K Current Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): June 10, 2021 MeiraGTx Holdings plc (Exact name of registrant as specified in its charter) ? ? ? ? ? ? Cayman Islands 001-38520 98-1448305 (State or other jurisdiction of incorpor |
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| May 11, 2021 |
? ? 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, 2021 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 Meira |
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| May 11, 2021 |
MeiraGTx Reports First Quarter 2021 Financial and Operational Results Exhibit 99.1 MeiraGTx Reports First Quarter 2021 Financial and Operational Results LONDON and NEW YORK, May 11, 2021 (GLOBE NEWSWIRE) - MeiraGTx Holdings plc (Nasdaq: MGTX), a vertically integrated, clinical stage gene therapy company, today announced financial results for the first quarter ended March 31, 2021 and provided an update on recent progress. ?During the first quarter of 2021, we contin |
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| May 11, 2021 |
Financial Statements and Exhibits, Results of Operations and Financial Condition ? ? UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K Current Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): May 11, 2021 MeiraGTx Holdings plc (Exact name of registrant as specified in its charter) ? ? ? ? ? ? Cayman Islands 001-38520 98-1448305 (State or other jurisdiction of incorpora |
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| April 28, 2021 |
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 (Amendment No. ) ? ? ? Filed by the Registrant ? Filed by a Party other than the Registrant ? Check the appropriate box: ? Preliminary Proxy Statement ? Confidential, for Use of the Commission Only (as permitted by R |
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| April 28, 2021 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 (Amendment No. ) ? Filed by the Registrant ? Filed by a Party other than the Registrant ? Check the appropriate box: ? Preliminary Proxy Statement ? Confidential, for Use of the Commission Only (as permitted by Rule 14a-6(e)(2)) ? Def |
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| March 11, 2021 |
Exhibit 99.1 MeiraGTx Reports Fourth Quarter and Full Year 2020 Financial and Operational Results -Preparing to Initiate Phase 3 Lumeos Clinical Trial in AAV-RPGR -Announced Positive Preliminary Clinical Data from AQUAx AAV-hAQP1 Phase 1 Trial for Treatment of Grade 2/3 Xerostomia -Completed Build of Internal cGMP Plasmid and DNA Manufacturing Facility -Strengthened Balance Sheet and Extended Cash |
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| March 11, 2021 |
Financial Statements and Exhibits, Results of Operations and Financial Condition ? ? UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K Current Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): March 11, 2021 MeiraGTx Holdings plc (Exact name of registrant as specified in its charter) ? ? ? ? ? ? Cayman Islands 001-38520 98-1448305 (State or other jurisdiction of incorpo |
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| March 11, 2021 |
Exhibit 21 ? SUBSIDIARIES OF MEIRAGTX HOLDINGS PLC ? ? Legal Name of Subsidiary Jurisdiction of Organization BRI-Alzan, Inc. |
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| March 11, 2021 |
Form of Change in Control Agreement ? Exhibit 10.14 CHANGE IN CONTROL AGREEMENT This Change in Control Agreement (?Agreement?) is made effective as of [], by and between [EMPLOYING SUBSIDIARY] (the ?Company?) and [] (?Executive?). WHEREAS, Executive is a key employee of the Company; WHEREAS, the Company recognizes that the possibility of a change in control and a related involuntary termination raises uncertainty and questions among |
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| March 11, 2021 |
Table of Contents ? ? UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D. |
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| March 11, 2021 |
Non-Employee Director Compensation Program. Exhibit 10.3 ? MEIRAGTX HOLDINGS PLC ? NON-EMPLOYEE DIRECTOR COMPENSATION PROGRAM ? Non-employee members of the board of directors (the ?Board?) of MeiraGTx Holdings plc (the ?Company?) shall receive cash and equity compensation as set forth in this Non-Employee Director Compensation Program (this ?Program?). The cash and equity compensation described in this Program shall be paid or be made, as a |
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| February 12, 2021 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G (Rule 13d-102) (Amendment No. 2)* MeiraGTx Holdings plc (Name of Issuer) Ordinary Shares, par value $0.00003881 nominal value per share (Title of Class of Securities) G59665 102 (CUSIP Number) December 31, 2020 (Date of Event which Requires Filing of this Statement) Check the appropriate box |
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| February 12, 2021 |
CUSIP No. G59665102 SCHEDULE 13G Page 8 of 8 Pages EXHIBIT A JOINT FILING AGREEMENT The undersigned hereby agree that the Statement on this Schedule 13G dated February 12, 2021 (the “Schedule 13G”), with respect to the Ordinary Shares, per value of $0.00003881 per share, of MeiraGTx Holdings plc is filed on behalf of each of us pursuant to and in accordance with the provisions of Rule 13d-1(k) und |
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| February 12, 2021 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 SCHEDULE 13G Under the Securities Exchange Act of 1934 (Amendment No. |
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| December 17, 2020 |
Regulation FD Disclosure, Financial Statements and Exhibits, Other Events - 8-K UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K Current Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): December 16, 2020 MeiraGTx Holdings plc (Exact name of registrant as specified in its charter) Cayman Islands 001-38520 98-1448305 (State or other jurisdiction of incorporation or org |
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| December 17, 2020 |
EXHIBIT 99.1 MeiraGTx To Present Clinical Program Update for AAV-hAQP1 Treatment of Radiation-Induced Xerostomia - Webcast and conference call to take place on December 17, 2020 at 8:00 a.m. ET - LONDON and NEW YORK, Dec. 16, 2020 (GLOBE NEWSWIRE) - MeiraGTx Holdings plc (Nasdaq: MGTX), a vertically integrated, clinical stage gene therapy company, today announced the Company will host a webcast an |
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| November 24, 2020 |
Amendment No. 3 to Schedule 13D SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13D/A Under the Securities Exchange Act of 1934 (Amendment No. 3)* MeiraGTx Holdings plc (Name of Issuer) Ordinary Shares, nominal value $0.00003881 per share (Title of Class of Securities) G59665 102 (CUSIP Number) Alexander Rakitin Perceptive Advisors LLC 51 Astor Place, 10th Floor New York, NY 100 |
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| November 23, 2020 |
Financial Statements and Exhibits, Other Events - FORM 8-K UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K Current Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): November 19, 2020 MeiraGTx Holdings plc (Exact name of registrant as specified in its charter) Cayman Islands 001-38520 98-1448305 (State or other jurisdiction of incorporation or org |
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| November 23, 2020 |
Exhibit 1.1 EXECUTION VERSION MeiraGTx Holdings plc (a Cayman Islands exempted company) 5,000,000 Ordinary Shares UNDERWRITING AGREEMENT Dated: November 19, 2020 MeiraGTx Holdings plc (a Cayman Islands exempted company) 5,000,000 ordinary shares, nominal value $0.00003881 per share UNDERWRITING AGREEMENT November 19, 2020 BofA Securities, Inc. Piper Sandler & Co. Evercore Group L.L.C. Barclays Cap |
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| November 19, 2020 |
TABLE OF CONTENTS ?Registration No. 333-232677 ?Filed Pursuant to Rule 424(b)(5)? PROSPECTUS SUPPLEMENT (To Prospectus dated July 19, 2019) 5,000,000 Ordinary Shares ? We are offering 5,000,000 of our ordinary shares, nominal value $0.00003881 per ordinary share. Our ordinary shares are listed on the Nasdaq Global Select Market under the symbol ?MGTX.? On November 18, 2020, the last reported sale |
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| November 18, 2020 |
Termination of a Material Definitive Agreement - FORM 8-K UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K Current Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): November 18, 2020 MeiraGTx Holdings plc (Exact name of registrant as specified in its charter) Cayman Islands 001-38520 98-1448305 (State or other jurisdiction of incorporation or org |
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| November 18, 2020 |
SUBJECT TO COMPLETION, DATED NOVEMBER 18, 2020 TABLE OF CONTENTS The information in this preliminary prospectus supplement and the accompanying base prospectus, relating to an effective registration statement under the Securities Act of 1933, as amended, is not complete and may be changed. |
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| November 16, 2020 |
Regulation FD Disclosure, Financial Statements and Exhibits, Other Events - 8-K UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K Current Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): November 13, 2020 MeiraGTx Holdings plc (Exact name of registrant as specified in its charter) Cayman Islands 001-38520 98-1448305 (State or other jurisdiction of incorporation or org |
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| November 16, 2020 |
Exhibit 99.1 MeiraGTx Announces Investigational Gene Therapy Continues to Demonstrate Statistically Significant Improvement in Vision in Patients with X-Linked Retinitis Pigmentosa One Year After Treatment ·Data presented at AAO 2020 Virtual Annual Meeting show sustained improvements in retinal sensitivity at 12 months LONDON and NEW YORK, November 13, 2020 (GLOBE NEWSWIRE) - MeiraGTx Holdings plc |
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| November 5, 2020 |
Exhibit 99.1 MeiraGTx Reports Third Quarter 2020 Financial Results - MeiraGTx preparing to initiate Phase 3 trial of AAV-RPGR - Plasmid production facility expected to be completed year-end 2020 LONDON and NEW YORK, November 5, 2020 - MeiraGTx Holdings plc (Nasdaq: MGTX), a vertically integrated, clinical stage gene therapy company, today announced financial results for the third quarter ended Sep |
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| November 5, 2020 |
Financial Statements and Exhibits, Results of Operations and Financial Condition - 8-K UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K Current Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): November 5, 2020 MeiraGTx Holdings plc (Exact name of registrant as specified in its charter) Cayman Islands 001-38520 98-1448305 (State or other jurisdiction of incorporation or orga |
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| November 5, 2020 |
Exhibit 10.2 WARNING: IT IS RECOMMENDED THAT THE WITHIN SHOULD NOT BE COMPLETED WITHOUT PRIOR LEGAL ADVICE Law Society of Ireland GENERAL CONDITIONS OF SALE 2019 EDITION PARTICULARS and CONDITIONS OF SALE of Building 3, Block K, Shannon Free Zone, Shannon, County Clare Vendor: Shannon Commercial Enterprises DAC trading as Shannon Commercial Properties Vendor’s Solicitor: HOLMES O’MALLEY SEXTON SOL |
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| November 5, 2020 |
Exhibit 10.1 WARNING: IT IS RECOMMENDED THAT THE WITHIN SHOULD NOT BE COMPLETED WITHOUT PRIOR LEGAL ADVICE Law Society of Ireland GENERAL CONDITIONS OF SALE 2019 EDITION PARTICULARS and CONDITIONS OF SALE of Building 2, Block K, Shannon Free Zone, Shannon, County Clare Vendor: Shannon Commercial Enterprises DAC trading as Shannon Commercial Properties Vendor’s Solicitor: HOLMES O’MALLEY SEXTON SOL |
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| November 5, 2020 |
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, 2020 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 Meira |
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| October 6, 2020 |
Regulation FD Disclosure, Financial Statements and Exhibits, Other Events - 8-K UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K Current Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): October 3, 2020 MeiraGTx Holdings plc (Exact name of registrant as specified in its charter) Cayman Islands 001-38520 Not applicable (State or other jurisdiction of incorporation or o |
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| October 6, 2020 |
Exhibit 99.1 MeiraGTx Announces Nine-Month Data from Phase 1/2 Trial of AAV-RPGR Demonstrating Significant and Sustained Vision Improvement in X-Linked Retinitis Pigmentosa (XLRP) · Data presented at EURETINA 2020 Virtual Congress show sustained improvements in retinal sensitivity at nine months · Significant improvements were also demonstrated in the time taken to walk through a vision-guided mob |
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| August 6, 2020 |
Exhibit 99.1 MeiraGTx Reports Second Quarter 2020 Financial Results - Positive initial data from Phase 1/2 clinical trial of AAV-RPGR for the treatment of XLRP recently presented - AAV-RPGR to advance into Phase 3 Lumeos clinical trial - Expands manufacturing capabilities with new facilities in Ireland LONDON and NEW YORK, August 6, 2020 (GLOBE NEWSWIRE) - MeiraGTx Holdings plc (Nasdaq: MGTX), a v |
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| August 6, 2020 |
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, 2020 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 H |
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| August 6, 2020 |
Financial Statements and Exhibits, Results of Operations and Financial Condition UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K Current Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): August 6, 2020 MeiraGTx Holdings plc (Exact name of registrant as specified in its charter) Cayman Islands 001-38520 Not applicable (State or other jurisdiction of incorporation or or |
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| July 17, 2020 |
Regulation FD Disclosure, Financial Statements and Exhibits, Other Events UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K Current Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): July 17, 2020 MeiraGTx Holdings plc (Exact name .of registrant as specified in its charter) Cayman Islands 001-38520 Not applicable (State or other jurisdiction of incorporation or or |
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| July 17, 2020 |
Exhibit 99.1 MeiraGTx Announces Positive Clinical Data Demonstrating Treatment with AAV-RPGR Investigational Gene Therapy Improves Vision in X-Linked Retinitis Pigmentosa Patients · Data being presented at the American Society of Retina Specialists (ASRS) 2020 Virtual Annual Meeting · Significant improvements demonstrated after treatment in Phase 1/2 clinical trial · Based on encouraging safety an |
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| June 8, 2020 |
Submission of Matters to a Vote of Security Holders UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8‑K Current Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): June 2, 2020 MeiraGTx Holdings plc (Exact name .of registrant as specified in its charter) Cayman Islands 001‑38520 Not applicable (State or other jurisdiction of incorporation or org |
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| May 26, 2020 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A INFORMATION Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 (Amendment No. ) Filed by the Registrant ☒ Filed by a Party other than the Registrant ☐ Check the appropriate box: ☐ Preliminary Proxy Statement ☐ Confidential, for Use of the Commission Only (as permitted by Rule 14a-6(e) |
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| May 7, 2020 |
Exhibit 10.1 SEPARATION AND RELEASE AGREEMENT I, Bruce Gottlieb, by my signature below resign from my employment and any and all other offices or directorships with MeiraGTx, LLC and any of its affiliates (“Meira” or the “Company”) without Good Reason as defined in my employment agreement dated March 25, 2019 (“Employment Agreement”), effective immediately, and understand that a severance package |
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| May 7, 2020 |
MeiraGTx Reports First Quarter 2020 Financial Results Exhibit 99.1 MeiraGTx Reports First Quarter 2020 Financial Results LONDON and NEW YORK, May 7, 2020 (GLOBE NEWSWIRE) - MeiraGTx Holdings plc (Nasdaq: MGTX), a vertically integrated, clinical stage gene therapy company, today announced financial results for the first quarter ended March 31, 2020 and provided an update on recent progress. During the first quarter of 2020, MeiraGTx remained focused o |
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| May 7, 2020 |
Financial Statements and Exhibits, Results of Operations and Financial Condition UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K Current Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): May 7, 2020 MeiraGTx Holdings plc (Exact name of registrant as specified in its charter) Cayman Islands 001‑38520 Not applicable (State or other jurisdiction of incorporation or organ |
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| May 7, 2020 |
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, 2020 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 Ho |
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| April 21, 2020 |
MGTX / MeiraGTx Holdings plc DEFA14A - - DEFA14A UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 (Amendment No. ) Filed by the Registrant x Filed by a Party other than the Registrant o Check the appropriate box: o Preliminary Proxy Statement o Confidential, for Use of the Commission Only (as permitted by Rule 14a-6(e)(2)) o Defin |
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| April 21, 2020 |
Definitive Proxy Statement on Schedule 14A, filed with the SEC on April 21, 2020. Use these links to rapidly review the document TABLE OF CONTENTS Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D. |
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| March 11, 2020 |
Financial Statements and Exhibits, Results of Operations and Financial Condition UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K Current Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): March 11, 2020 MeiraGTx Holdings plc (Exact name of registrant as specified in its charter) Cayman Islands 001‑38520 Not applicable (State or other jurisdiction of incorporation or or |
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| March 11, 2020 |
Exhibit 10.31 MEIRAGTX HOLDINGS PLC 2018 INCENTIVE AWARD PLAN UK SUB-PLAN RESTRICTED SHARE UNIT GRANT NOTICE FOR UK PARTICIPANTS Capitalized terms not specifically defined in this Restricted Share Unit Grant Notice for UK Participants (the “Grant Notice”) have the meanings given to them in the 2018 Incentive Award Plan UK Sub-Plan (the “UK Sub-Plan”) of MeiraGTx Holdings plc (the “Company”), which |
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| March 11, 2020 |
Exhibit 21 SUBSIDIARIES OF MEIRAGTX HOLDINGS PLC Legal Name of Subsidiary Jurisdiction of Organization BRI-Alzan, Inc. Delaware MeiraGTx B.V. Netherlands Arthrogen B.V. Netherlands MeiraGTx Limited England and Wales MeiraGTx, LLC Delaware MeiraGTx UK Limited England and Wales MeiraGTx UK II Limited England and Wales MeiraGTx Neurosciences, Inc. Delaware |
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| March 11, 2020 |
MeiraGTx Reports Full Year 2019 Financial Results Exhibit 99.1 MeiraGTx Reports Full Year 2019 Financial Results LONDON and NEW YORK, March 11, 2020 (GLOBE NEWSWIRE) - MeiraGTx Holdings plc (Nasdaq: MGTX), a vertically integrated, clinical stage gene therapy company, today announced financial results for the full year ended December 31, 2019 and provided an update on recent progress. “During 2019, the MeiraGTx team reached meaningful milestones, |
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| March 11, 2020 |
Non-Employee Director Compensation Program. Exhibit 10.3 MEIRAGTX HOLDINGS PLC NON-EMPLOYEE DIRECTOR COMPENSATION PROGRAM Non-employee members of the board of directors (the “Board”) of MeiraGTx Holdings plc (the “Company”) shall receive cash and equity compensation as set forth in this Non-Employee Director Compensation Program (this “Program”). The cash and equity compensation described in this Program shall be paid or be made, as applica |
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| March 11, 2020 |
MGTX / MeiraGTx Holdings plc 10-K - Annual Report - 10-K 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, 2019 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 |
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| March 11, 2020 |
Exhibit 10.30 MEIRAGTX HOLDINGS PLC 2018 INCENTIVE AWARD PLAN RESTRICTED SHARE UNIT GRANT NOTICE Capitalized terms not specifically defined in this Restricted Share Unit Grant Notice (the “Grant Notice”) have the meanings given to them in the 2018 Incentive Award Plan (as amended from time to time, the “Plan”) of MeiraGTx Holdings plc (the “Company”). The Company has granted to the participant lis |
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| March 11, 2020 |
Exhibit 4.2 SHAREHOLDER AGREEMENT OF MEIRAGTX HOLDINGS PLC DATED AS OF 7 JUNE 2018 Table of Contents SECTION 1. DEFINITIONS 1 SECTION 2. FORMATION, PURPOSE, TERM 3 2.1 NAME 3 2.2 PURPOSES 3 2.3 POWERS 4 2.4 REGISTERED OFFICE 4 2.5 ORGANIZATION EXPENSES 4 2.6 REGISTER OF MEMBERS; TRANSFER 4 2.7 PROPOSED IPO 4 SECTION 3. MEMBERS; SHARE RIGHTS 5 3.2 RESERVED MATTERS. THE FOLLOWING MATTERS SHALL REQUI |
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| March 11, 2020 |
Exhibit 4.3 DESCRIPTION OF SECURITIES The following summary of MeiraGTx Holdings plc’s (the “Company”) ordinary shares is based on and qualified by the Company’s amended and restated memorandum and articles of association. In this “Description of Securities” discussion, we use the terms “we,” “us” and “our” to refer to the Company. General We were incorporated pursuant to the laws of the Cayman Is |
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| March 2, 2020 |
MGTX / MeiraGTx Holdings plc / ADENA ESTATE INC. - SCHEDULE 13G Passive Investment UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G Under the Securities Exchange Act of 1934 (Amendment No. )* MeiraGTx Holdings plc (Name of Issuer) Ordinary shares, nominal value $0.00003881 per share (Title of Class of Securities) G59665 102 (CUSIP Number) June 8th 2018 (Date of Event Which Requires Filing of this Statement) Check the appropriate box to designa |
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| February 14, 2020 |
MGTX / MeiraGTx Holdings plc / ORBIMED ADVISORS LLC Passive Investment UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 SCHEDULE 13G Under the Securities Exchange Act of 1934 (Amendment No. |
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| February 14, 2020 |
MGTX / MeiraGTx Holdings plc / Kadmon Holdings, Inc. - KDMN SC 13GA Passive Investment UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G (Rule 13d-102) (Amendment No. 1)* MeiraGTx Holdings plc (Name of Issuer) Ordinary Shares, par value $0.00003881 nominal value per share (Title of Class of Securities) G59665 102 (CUSIP Number) December 31, 2019 (Date of Event which Requires Filing of this Statement) Check the appropriate box |
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| February 14, 2020 |
MGTX / MeiraGTx Holdings plc / ALEXANDRIA REAL ESTATE EQUITIES INC - SC 13G Passive Investment UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G Under the Securities Exchange Act of 1934 MeiraGTx Holdings plc (Name of Issuer) Ordinary Shares, $0.00003881 par value per share (Title of Class of Securities) G59665 102 (CUSIP Number) December 31, 2019 (Date of Event Which Requires Filing of This Statement) Check the appropriate box to designate the rule pursua |
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| December 31, 2019 |
8-K/A UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K/A (Amendment No. 1) Current Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): February 19, 2019 MeiraGTx Holdings plc (Exact name of registrant as specified in its charter) Cayman Islands 001-38520 Not applicable (State or other jurisd |
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| November 7, 2019 |
MGTX / MeiraGTx Holdings plc 10-Q - Quarterly Report - 10-Q 10-Q Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D. |
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| November 7, 2019 |
MeiraGTx Reports Third Quarter 2019 Financial Results EX-99.1 Exhibit 99.1 MeiraGTx Reports Third Quarter 2019 Financial Results LONDON and NEW YORK, November 7, 2019 (GLOBE NEWSWIRE) — MeiraGTx Holdings plc (Nasdaq: MGTX), a vertically integrated, clinical stage gene therapy company, today announced financial results for the quarter ended September 30, 2019 and provided an update on recent progress. “Over the course of the third quarter, we continue |
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| November 7, 2019 |
Financial Statements and Exhibits, Results of Operations and Financial Condition 8-K UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K Current Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): November 7, 2019 MeiraGTx Holdings plc (Exact name of registrant as specified in its charter) Cayman Islands 001-38520 Not applicable (State or other jurisdiction of incorporation |
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| August 20, 2019 |
Amendment No. 2 to Schedule 13D SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13D/A Under the Securities Exchange Act of 1934 (Amendment No. 2)* MeiraGTx Holdings plc (Name of Issuer) Ordinary Shares, nominal value $0.00003881 per share (Title of Class of Securities) G59665 102 (CUSIP Number) Alexander Rakitin Perceptive Advisors LLC 51 Astor Place, 10th Floor New York, NY 100 |
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| August 9, 2019 |
Financial Statements and Exhibits, Other Events 8-K UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K Current Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): August 7, 2019 MeiraGTx Holdings plc (Exact name of registrant as specified in its charter) Cayman Islands 001-38520 Not applicable (State or other jurisdiction of incorporation o |
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| August 9, 2019 |
EX-1.1 Exhibit 1.1 EXECUTION VERSION MeiraGTx Holdings plc (a Cayman Islands exempted company) 3,200,000 Ordinary Shares UNDERWRITING AGREEMENT Dated: August 7, 2019 MeiraGTx Holdings plc (a Cayman Islands exempted company) 3,200,000 ordinary shares, nominal value $0.00003881 per share UNDERWRITING AGREEMENT BofA Securities, Inc. August 7, 2019 Piper Jaffray & Co. as Representatives of the several |
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| August 9, 2019 |
3,200,000 Ordinary Shares Ordinary Shares 424B5 Table of Contents Registration No. 333-232677 Filed Pursuant to Rule 424(b)(5) PROSPECTUS SUPPLEMENT (To Prospectus dated July 19, 2019) 3,200,000 Ordinary Shares Ordinary Shares We are offering 3,200,000 ordinary shares at a public offering price of $23.50 per ordinary share. Our ordinary shares are listed on the Nasdaq Global Select Market under the symbol “MGTX.” On August 7, 2019, the la |
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| August 7, 2019 |
Subject to Completion Preliminary Prospectus Dated August 7, 2019. 424B5 Table of Contents Registration No. 333-232677 Filed Pursuant to Rule 424(b)(5) The information in this preliminary prospectus supplement and the accompanying base prospectus, relating to an effective registration statement under the Securities Act of 1933, as amended, is not complete and may be changed. A registration statement relating to these securities has been declared effective by the |
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| August 7, 2019 |
Financial Statements and Exhibits, Results of Operations and Financial Condition 8-K UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K Current Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): August 7, 2019 MeiraGTx Holdings plc (Exact name of registrant as specified in its charter) Cayman Islands 001-38520 Not applicable (State or other jurisdiction of incorporation o |
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| August 7, 2019 |
MeiraGTx Reports Second Quarter 2019 Financial Results and Provides Corporate Update EX-99.1 Exhibit 99.1 MeiraGTx Reports Second Quarter 2019 Financial Results and Provides Corporate Update LONDON and NEW YORK, August 7, 2019 (GLOBE NEWSWIRE) — MeiraGTx Holdings plc (Nasdaq: MGTX), a vertically integrated, clinical stage gene therapy company, today announced financial results for the quarter ended June 30, 2019 and provided an update on recent clinical progress. MeiraGTx today an |
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| August 7, 2019 |
License and Sub-Lease Agreement, dated May 31, 2019, between MeiraGTx LLC and Imclone Systems, LLC. EX-10.2 Exhibit 10.2 AGREEMENT OF SUBLEASE IMCLONE SYSTEMS, LLC, as Sublandlord and MEIRAGTX, LLC, as Subtenant PREMISES AT 450 East 29th Street NEW YORK, NEW YORK Entire 14th Floor May 31, 2019 TABLE OF CONTENTS Paragraph Page 1. Term 1 2. Fixed Rent 2 3. Use of the Sublease Premises 3 4. Incorporation of Overlease Terms, No Violoation of Overlease 3 5. Sublease Subject to Overlease 4 6. Inapplic |
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| August 7, 2019 |
EX-3.2 Exhibit 3.2 ANNEX A AMENDED AND RESTATED MEMORANDUM AND ARTICLES OF ASSOCIATION THE COMPANIES LAW (AS AMENDED) COMPANY LIMITED BY SHARES AMENDED AND RESTATED MEMORANDUM OF ASSOCIATION OF MEIRAGTX HOLDINGS PLC (ADOPTED BY SPECIAL RESOLUTION DATED 8 JUNE 2018 2019) REF: CM/SP/M6113-151627 THE COMPANIES LAW (AS AMENDED) COMPANY LIMITED BY SHARES AMENDED AND RESTATED MEMORANDUM OF ASSOCIATION O |
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| August 7, 2019 |
MGTX / MeiraGTx Holdings plc 10-Q - Quarterly Report - 10-Q 10-Q Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D. |
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| August 7, 2019 |
EX-10.3 Exhibit 10.3 Dated 29th May 2019 Agreement for Lease with Landlord’s Refurbishment Works relating to 34-38 Provost Street London N1 7NG (1) Provost 1 Limited and Provost 2 Limited (2) Meiragtx UK II Limited Harbottle & Lewis LLP T + 44 (0)20 7667 5000 Hanover House F + 44 (0)20 7667 5100 14 Hanover Square www.harbottle.com London DX 44617 Mayfair W1S 1HP Ref: 145/319442/3 CONTENTS CLAUSE 1 |
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| August 7, 2019 |
Amended and Restated Memorandum and Articles of Association of the Registrant. EX-3.1 Exhibit 3.1 ANNEX A AMENDED AND RESTATED MEMORANDUM AND ARTICLES OF ASSOCIATION THE COMPANIES LAW (AS AMENDED) COMPANY LIMITED BY SHARES AMENDED AND RESTATED MEMORANDUM OF ASSOCIATION OF MEIRAGTX HOLDINGS PLC (ADOPTED BY SPECIAL RESOLUTION DATED 2019) REF: CM/SP/M6113-151627 THE COMPANIES LAW (AS AMENDED) COMPANY LIMITED BY SHARES AMENDED AND RESTATED MEMORANDUM OF ASSOCIATION OF MEIRAGTX H |
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| July 18, 2019 |
MGTX / MeiraGTx Holdings plc CORRESP - - CORRESP MEIRAGTX HOLDINGS 430 EAST 29TH STREET, 10TH FLOOR NEW YORK, NY 10016 July 18, 2019 VIA EDGAR TRANSMISSION Securities and Exchange Commission Division of Corporation Finance Mail Stop 4720 100 F Street, N. |
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| July 16, 2019 |
S-3 Table of Contents As filed with the Securities and Exchange Commission on July 16, 2019 Registration No. |
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| July 16, 2019 |
EX-1.2 Exhibit 1.2 MEIRAGTX HOLDINGS PLC Ordinary Shares (nominal value $0.00003881 per share) Sales Agreement July 16, 2019 Chardan Capital Markets, LLC 17 State Street, Suite 1600 New York, New York 10004 Ladies and Gentlemen: MeiraGTx Holdings plc, a Cayman Islands exempted company (the “Company”), confirms its agreement (this “Agreement”) with Chardan Capital Markets, LLC (the “Agent”), as fol |
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| July 12, 2019 |
MGTX / MeiraGTx Holdings plc CORRESP - - CORRESP MEIRAGTX HOLDINGS 430 EAST 29TH STREET, 10TH FLOOR NEW YORK, NY 10016 July 12, 2019 VIA EDGAR TRANSMISSION Securities and Exchange Commission Division of Corporation Finance Mail Stop 4720 100 F Street, N. |
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| July 2, 2019 |
MGTX / MeiraGTx Holdings plc S-3 - - S-3 S-3 Table of Contents As filed with the Securities and Exchange Commission on July 2, 2019 Registration No. |
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| June 20, 2019 |
Submission of Matters to a Vote of Security Holders 8-K UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K Current Report Pursuant to Section 13 OR 15(d) of The Securities Exchange Act of 1934 Date of Report (Date of earliest event reported) June 19, 2019 MeiraGTx Holdings plc (Exact name of registrant as specified in its charter) Cayman Islands 001-38520 Not applicable (State or other jurisdiction of incorporation) (C |
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| June 4, 2019 |
EX-10.1 Exhibit 10.1 SEPARATION AND RELEASE AGREEMENT I, Katherine Breedis, understand that my employment with MeiraGTx, LLC (“Meira” or the “Company”) has been terminated, as mutually agreed, effective April 16, 2019 and that a severance package is being made available to me in exchange for signing this Separation and Release Agreement (“Release”). 1. I understand that in exchange for signing thi |
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| June 4, 2019 |
8-K UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K Current Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): June 3, 2019 MeiraGTx Holdings plc (Exact name of registrant as specified in its charter) Cayman Islands 001-38520 Not applicable (State or other jurisdiction of incorporation or |
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| May 15, 2019 |
EX-99.1 Exhibit 99.1 MeiraGTx Reports First Quarter 2019 Financial Results and Provides Corporate Update ● Positive 6-month results from Phase 1/2 clinical trial of AAV-RPE65 ● Enrollment completed in the Phase 1/2 clinical trial investigating AAV-CNGB3 gene therapy for the treatment of achromatopsia LONDON and NEW YORK, May 14, 2019 (GLOBE NEWSWIRE) — MeiraGTx Holdings plc (NASDAQ:MGTX), a vertic |
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| May 15, 2019 |
Financial Statements and Exhibits, Results of Operations and Financial Condition 8-K UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K Current Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): May 14, 2019 MeiraGTx Holdings plc (Exact name of registrant as specified in its charter) Cayman Islands 001-38520 Not applicable (State or other jurisdiction of incorporation or |
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| May 14, 2019 |
Employment Agreement, dated March 25, 2019, between MeiraGTx, LLC and Bruce Gottlieb. EX-10.1 Exhibit 10.1 March 25, 2019 Mr. Bruce Gottlieb Dear Bruce: This letter shall formalize our offer of employment with MeiraGTx, LLC (Meira), a subsidiary of MeiraGTx Limited, a subsidiary of MeiraGTx Holdings plc (together, the Company) as General Counsel reporting solely and directly to Alexandria Forbes, Chief Executive Officer. Your employment will begin on April 1, 2019. Your employm |
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| May 14, 2019 |
MGTX / MeiraGTx Holdings plc 10-Q Quarterly Report 10-Q 10-Q Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D. |
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| May 10, 2019 |
MeiraGTx Appoints Nicole Seligman to Board of Directors EX-99.1 Exhibit 99.1 MeiraGTx Appoints Nicole Seligman to Board of Directors LONDON and NEW YORK, May 10, 2019 (GLOBE NEWSWIRE) MeiraGTx Holdings plc (NASDAQ:MGTX), a vertically integrated, clinical stage gene therapy company, today announced the appointment of Nicole Seligman to its Board of Directors. Ms. Seligman is an accomplished leader with extensive executive, legal, compliance and govern |
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| May 10, 2019 |
8-K UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K Current Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): May 9, 2019 MeiraGTx Holdings plc (Exact name of registrant as specified in its charter) Cayman Islands 001-38520 Not applicable (State or other jurisdiction of incorporation or o |
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| April 29, 2019 |
MGTX / MeiraGTx Holdings plc DEFA14A DEFA14A DEFA14A UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A INFORMATION Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 (Amendment No. ) Filed by the Registrant ☒ Filed by a Party other than the Registrant ☐ Check the appropriate box: ☐ Preliminary Proxy Statement ☐ Confidential, for Use of the Commission Only (as permitted by Rule |
