LONDON and NEW YORK, Aug. 06, 2020 (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, 2020 and provided an update on recent clinical development and business progress, including the Company’s new cGMP viral vector manufacturing and plasmid production facilities in Shannon, Ireland.

“The first half of 2020 has been marked by notable achievements for MeiraGTx, including the recent presentation of positive clinical data on our investigational therapy for people with the severe inherited retinal disease X-linked retinitis pigmentosa, which demonstrate that AAV-RPGR treatment improved vision and support advancing the program into a pivotal trial,” said Alexandria Forbes, Ph.D., president and chief executive officer of MeiraGTx.

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 we advance and expand our clinical pipeline of potential gene therapy products, our flexible and scalable cGMP manufacturing capabilities become increasingly critical in enabling the efficient and timely development of these potential therapies,” continued Dr. Forbes. “We look forward to working with the local community in Shannon, Ireland as we establish our second cGMP viral vector manufacturing facility and our cGMP plasmid production facility. We expect our plasmid production facility to be operational by the end of 2020, and our second viral vector manufacturing facility to be operational by the end of 2021.”

As of June 30, 2020, MeiraGTx had cash and cash equivalents of $194.8 million. In addition, the Company expects approximately $24.4 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

• Initial positive clinical data from MeiraGTx’s ongoing Phase 1/2 clinical study (MGT009) of AAV-RPGR were presented as a late-breaker oral presentation at the American Society of Retina Specialists (ASRS) 2020 Virtual Annual Meeting in July 2020.
• Six-month data from the dose escalation portion of the trial (n=10) demonstrated meaningful improvement from baseline in retinal sensitivity in the low (n=3) and intermediate (n=4) dose cohorts. Importantly, these improvements were evident when assessed with two perimetry approaches (static perimetry and microperimetry) and three analysis metrics (mean retinal sensitivity, central 30° hill-of-vision volumetric measure (V30), and pointwise comparison).
• Based on the encouraging safety and efficacy data demonstrated in the MGT009 trial to date, MeiraGTx and Janssen expect to advance AAV-RPGR into the Phase 3 Lumeos clinical trial for the treatment of patients with XLRP caused by mutations in RPGR gene.

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

• In response to the COVID-19 pandemic, MeiraGTx continues to work closely with clinical sites to enable continuity of the Company’s ongoing AQUAx clinical trial. New patient enrollment in the trial has resumed, and patients who have been treated in the trial are continuing to undergo post-treatment follow-up assessments.
• MeiraGTx anticipates reporting preliminary clinical data from the AAV-AQP1 program by the end of 2020.

AAV-GAD for the Treatment of Parkinson’s Disease

• Manufacturing of AAV-GAD material is ongoing at the Company’s London cGMP facility. MeiraGTx expects to file an Investigational New Drug (IND) application in early 2021 following the release of the clinical material.

Manufacturing and Supply Chain

• MeiraGTx has selected Shannon, Ireland as the site of the Company’s second cGMP viral vector manufacturing facility and cGMP plasmid production facility. These facilities will be designed for the manufacture of commercial-grade gene therapies in a fully integrated manner supported by MeiraGTx’s global quality assurance organization. MeiraGTx expects the Irish facilities to provide additional flexibility as well as further large-scale capacity for clinical and commercial supply of its gene therapy product candidates from first-in-man clinical trials through potential commercialization. This project is supported by the Irish Government through IDA Ireland.
• The plasmid production facility is expected to be operational by the end of 2020, and the viral vector manufacturing facility is expected to be operational by the end of 2021.

Strengthened Senior Leadership Team

• MeiraGTx appointed Robert K. Zeldin, M.D. as Chief Medical Officer. In this role, Dr. Zeldin oversees the development of MeiraGTx’s six clinical stage gene therapy programs.

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

Financial Results

License revenue was $2.5 million for the quarter ended June 30, 2020, compared to $2.0 million for the quarter ended June 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 $16.2 million for the quarter ended June 30, 2020, compared to $9.8 million for the quarter ended June 30, 2019. The increase of $6.4 million was primarily due to an increase for the non-cash acquisition costs of Emrys Bio, Inc. and increases in costs related to the manufacture of material for clinical trials, payroll and payroll related costs and share-based compensation, which was partially offset by an increase in research funding provided under our collaboration agreement with Janssen and a decrease in costs related to our clinical trials.

General and administrative expenses were $11.5 million for the quarter ended June 30, 2020, compared to $13.4 million for the quarter ended June 30, 2019. The decrease of $1.9 million was primarily due to decreases in payroll and payroll related costs, which was partially offset by increases in rent and facilities costs, insurance costs and consulting fees.

Foreign currency loss was $0.4 million for the quarter ended June 30, 2020, compared to a gain of $0.3 million for the quarter ended June 30, 2019. The increase in the loss of $0.7 million was primarily due to a strengthening of the U.S. dollar against the pound sterling during the three months ended June 30, 2020.

Net loss attributable to ordinary shareholders for the quarter ended June 30, 2020 was $25.4 million, or $0.69 basic and diluted net loss per ordinary share, compared to a net loss attributable to ordinary shareholders of $20.8 million, or $0.63 basic and diluted net loss per ordinary share for the quarter ended June 30, 2019.

Cash and cash equivalents were $194.8 million for the quarter ended June 30, 2020, compared to $204.4 million as of June 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 future to develop additional gene therapy treatments for patients suffering from a range of serious diseases.

For more information, please visit www.meiragtx.com.