MeiraGTx Holdings plc Files 8-K

TL;DR

MeiraGTx filed an 8-K on 10/15/24 covering Reg FD, other events, and financials.

AI Summary

MeiraGTx Holdings plc filed an 8-K on October 15, 2024, reporting on various events. The filing includes information related to Regulation FD Disclosure, Other Events, and Financial Statements and Exhibits. The company's principal executive offices are located at 450 East 29th Street, 14th Floor, New York, NY 10016.

Why It Matters

This 8-K filing provides important updates and disclosures from MeiraGTx Holdings plc to the public and investors, covering regulatory, operational, and financial information.

Risk Assessment

Risk Level: low — This filing is a routine disclosure and does not appear to contain significant negative news or events.

Key Players & Entities

• MeiraGTx Holdings plc (company) — Registrant
• October 15, 2024 (date) — Date of Report
• 450 East 29th Street, 14th Floor, New York, NY 10016 (location) — Principal executive offices

FAQ

Key Financial Figures

• $0.00003881 — on which registered Ordinary Shares, $0.00003881 par value per share MGTX The Nasda

Filing Documents

• mgtx-20241015x8k.htm (8-K) — 51KB
• mgtx-20241015xex99d1.htm (EX-99.1) — 31KB
• mgtx-20241015xex99d1002.jpg (GRAPHIC) — 3KB
• 0001558370-24-013273.txt ( ) — 217KB
• mgtx-20241015.xsd (EX-101.SCH) — 3KB
• mgtx-20241015_lab.xml (EX-101.LAB) — 16KB
• mgtx-20241015_pre.xml (EX-101.PRE) — 10KB
• mgtx-20241015x8k_htm.xml (XML) — 5KB

01

Item 7.01 Regulation FD Disclosure. On October 15, 2024, MeiraGTx Holdings plc (the "Company") issued a press release announcing positive top-line data from the Company's clinical bridging study of AAV-GAD for the treatment of Parkinson's disease. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K ("Form 8-K") and is incorporated herein by reference. The information in this Item 7.01 of this Current Report on Form 8-K (including Exhibit 99.1) shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), or otherwise subject to the liabilities of that Section, nor shall it be deemed to be incorporated by reference into any filing of the Company under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.

01 Other Events

Item 8.01 Other Events. Recent Developments On October 15, 2024, the Company announced positive top-line data from the Company's clinical bridging study of AAV-GAD (MGT-GAD-025), an investigational gene therapy for the treatment of Parkinson's disease. MGT-GAD-025 is a 6-month, three-arm, randomized, double-blind, sham-controlled study using AAV-GAD drug product manufactured by the Company at its wholly-owned facilities with its commercial platform process. Participants had idiopathic Parkinson's disease, a history of levodopa responsiveness for at least 12 months, and a Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 score of 25 points in the "off" state. Fourteen subjects were randomized to one of three groups (high dose n=5, low dose n=5, and sham n=4). Top-line Data Summary AAV-GAD was safe and well tolerated with no serious adverse events (SAEs) related to AAV-GAD treatment. At Week 26, a statistically significant 18-point average improvement from baseline in UPDRS Part 3 "off" medication score was demonstrated in the high dose group (p= 0.03), with no significant change in the sham or low dose groups. Significant improvements from baseline in the disease-specific, patient-reported quality of life PDQ-39 sco

01. Financial Statements and Exhibits

Item 9.01. Financial Statements and Exhibits. (d) Exhibits. Exhibit No. Description 99.1 Press release of MeiraGTx Holdings plc, dated October 15, 2024. 104 Cover Page Interactive Data File (the cover page XBRL tags are embedded in the Inline XBRL document). 3 SIGNATURE Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized. Date: October 15, 2024 MEIRAGTX HOLDINGS PLC By: /s/ Richard Giroux Name: Richard Giroux Title: Chief Financial Officer and Chief Operating Officer 4

View Full Filing

View this 8-K filing on SEC EDGAR