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.   
  

AAV-AQP1 for the Treatment of Grade 2/3 Radiation-Induced Xerostomia

• In response to the COVID-19 pandemic, MeiraGTx is working with clinical sites to enable continuity of the AQUAx clinical trial in accordance with local regulations and site policies. Monitoring of enrolled subjects continues and start up activities for new sites have resumed.
• MeiraGTx expects to report preliminary data from the first treatment cohort of the AQUAx trial by the end of 2020.

AAV-GAD for the Treatment of Parkinson’s Disease:

• MeiraGTx continues to expect to file an Investigational New Drug (IND) application in the first half of 2021 following the release of the clinical material manufactured at the Company’s London cGMP facility.
  

Manufacturing and Supply Chain

• Construction of MeiraGTx’s Shannon, Ireland manufacturing campus is progressing. The campus will house the Company’s first cGMP plasmid production facility and MeiraGTx’s second cGMP viral vector manufacturing facility. The Shannon campus will provide additional flexibility and large-scale capacity for clinical and commercial supply of MeiraGTx’s gene therapy product candidates.
• Construction and commissioning activity remain on track, with the plasmid facility expected to be completed at the end of 2020, and the viral vector facility expected to be completed by year-end 2021. Hiring of highly skilled bio-process engineering, manufacturing and quality professionals in Ireland has commenced with several new employees expected by the end of 2020.
• MeiraGTx’s cGMP viral vector manufacturing facility in London was re-certified in the second quarter of 2020 by the Medicines & Healthcare Products Regulatory Agency (MHRA).
  

For more information related to our clinical trials, please visit www.clinicaltrials.gov

Financial Results

License revenue was $5.1 million for the quarter ended September 30, 2020, compared to $3.6 million for the quarter ended September 30, 2019. The increase represents increased amortization of the $100.0 million upfront payment that the Company received in March 2019 from its collaboration agreement with Janssen.

Research and development expenses were $4.6 million for the quarter ended September 30, 2020, compared to $4.6 million for the quarter ended September 30, 2019. Expenses primarily consisted of costs related to pre-clinical research and clinical trials, costs related to the manufacture of material for clinical trials, payroll and payroll related costs and share-based compensation, which were partially offset by research funding provided under our collaboration agreement with Janssen.

General and administrative expenses were $8.9 million for the quarter ended September 30, 2020, compared to $9.9 million for the quarter ended September 30, 2019. The decrease was primarily due to decreases in payroll and payroll related costs and travel costs, which were partially offset by increases in rent and facilities costs, insurance costs, legal and accounting fees and other office-related costs.

Foreign currency gain was $1.9 million for the quarter ended September 30, 2020, compared to a gain of $0.1 million for the quarter ended September 30, 2019. The increase was primarily due to a weakening of the U.S. dollar against the pound sterling.

Net loss attributable to ordinary shareholders for the quarter ended September 30, 2020 was $6.4 million, or $ (0.17) basic and diluted net loss per ordinary share, compared to a net loss attributable to ordinary shareholders of $10.5 million, or $(0.30) basic and diluted net loss per ordinary share for the quarter ended September 30, 2019.

Cash, cash equivalents and restricted cash were $179.3 million for the quarter ended September 30, 2020, compared to $253.3 million as of September 30, 2019.

About MeiraGTx
MeiraGTx (Nasdaq: MGTX) is a vertically integrated, clinical stage gene therapy company with six programs in clinical development and a broad pipeline of preclinical and research programs. MeiraGTx has core capabilities in viral vector design and optimization and gene therapy manufacturing, as well as a potentially transformative gene regulation technology. Led by an experienced management team, MeiraGTx has taken a portfolio approach by licensing, acquiring and developing technologies that give depth across both product candidates and indications. MeiraGTx’s initial focus is on three distinct areas of unmet medical need: inherited retinal diseases, neurodegenerative diseases and severe forms of xerostomia. Though initially focusing on the eye, central nervous system and salivary gland, MeiraGTx intends to expand its focus in the fu