MeiraGTx Reports Third Quarter 2020 Financial Results - Seite 2

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.