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,, Nov. 05, 2020 (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, 2020 and provided an update on recent clinical development and business progress.

“As we prepare to initiate our first pivotal trial, we continue to be encouraged by data emerging from our Phase 1/2 clinical trial of AAV-RPGR for the treatment of X-linked retinitis pigmentosa,” said Alexandria Forbes, Ph.D., president and chief executive officer of MeiraGTx. “We continued to make significant progress this quarter advancing our programs, and we look forward to providing additional clinical updates through the end of the year.”

MeiraGTx and Janssen Pharmaceuticals, Inc. (Janssen), one of the Janssen Pharmaceutical Companies of Johnson & Johnson, are jointly developing AAV-RPGR as part of a broader collaboration to develop and commercialize gene therapies for the treatment of inherited retinal diseases.

As of September 30, 2020, MeiraGTx had cash, cash equivalents and restricted cash of $179.3 million. In addition, the Company expects approximately $26.6 million in receivables from development partner Janssen in the next 90 days. MeiraGTx believes this capital will be sufficient to fund operating expenses and capital expenditure requirements into 2022.

Recent Clinical Development and Corporate Updates

AAV-RPGR for the Treatment of X-Linked Retinitis Pigmentosa (XLRP)

• Nine-month data from MeiraGTx’s ongoing Phase 1/2 clinical study (MGT009) of AAV-RPGR were presented at the EURETINA 2020 Virtual Meeting in October. Data at the nine-month time point continued to demonstrate significant, sustained vision improvement following treatment with AAV-RPGR in both the low (n=3) and intermediate (n=4) dose cohorts.
• Twelve-month data from the study will be presented at the American Academy of Ophthalmology (AAO) 2020 Virtual Annual Meeting on November 13, 2020.
• MeiraGTx and development partner Janssen are preparing to initiate the pivotal Phase 3 Lumeos clinical trial of AAV-RPGR in patients with XLRP.