Press release
MeiraGTx Reports Second Quarter 2021 Financial and Operational Results
LONDON and NEW YORK, Aug. 11, 2021 (GLOBE NEWSWIRE) -- MeiraGTx Holdings plc (Nasdaq: MGTX), a vertically integrated, clinical stage gene therapy company,
About this update from Meiragtx Holdings Plc
[{"type":"text","content":"LONDON and NEW YORK, Aug. 11, 2021 (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, 2021 and provided an update on recent progress. “As we move into the second half of 2021, we are enthusiastic about the progress of our clinical programs and our gene regulation technology,” said Alexandria Forbes, Ph.D., president and chief executive officer of MeiraGTx. “Our leading position in XLRP has been strengthened as we head into our Phase 3 pivotal trial for this large unmet need. We also remain on track to complete enrollment in our Phase 1 AQUAx study in grade 2/3 radiation-induced xerostomia this year and file our IND for AAV-GAD for Parkinson’s Disease.” Dr. Forbes continued, “In a testament to the quality and expertise of our manufacturing team at MeiraGTx, we anticipate having at least six different clinical programs using material made and released from our cGMP facilities in the next 12 months. Our proprietary process and end-to-end capabilities have allowed us to successfully manufacture products using multiple capsids and genes across ocular, neurodegenerative, and salivary gland programs.” As of June 30, 2021, MeiraGTx had cash and cash equivalents of approximately $172.6 million, as well as approximately $18.0 million due in receivables from development partner Janssen Pharmaceuticals, Inc. (Janssen), one of the Janssen Pharmaceutical Companies of Johnson & Johnson, as part of a broader collaboration to develop and commercialize gene therapies for the treatment of inherited retinal diseases. The Company believes it will have sufficient capital to fund operating expenses and capital expenditure requirements into the second quarter of 2023. Anticipated Upcoming Milestones and Corporate Activities Initiate, with Janssen, the Phase 3 Lumeos clinical trial evaluating AAV-RGPR as a treatment for patients with X-Linked retinitis pigmentosa (XLRP) in the second half of 2021.Initiate a Phase 3 pivotal trial of AAV-RPE65 for patients with RPE65-associated retinal dystrophy in the second half of 2021.Complete enrollment of the Phase 1 AQUAx trial of AAV-AQP1 for the treatment for Grade 2/3 radiation-induced xerostomia in the second half of 2021.File Investigational New Drug (IND) application for...