Press release
MeiraGTx Reports First Quarter 2021 Financial and Operational Results
LONDON and NEW YORK, May 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, May 11, 2021 (GLOBE NEWSWIRE) -- MeiraGTx Holdings plc (Nasdaq: MGTX), a vertically integrated, clinical stage gene therapy company, today announced financial results for the first quarter ended March 31, 2021 and provided an update on recent progress. “During the first quarter of 2021, we continued to advance our clinical and preclinical programs, as well as our proprietary cGMP manufacturing process. We are progressing rapidly with our riboswitch gene regulation technology platform and we are excited to share in-vivo data later this year,” said Alexandria Forbes, Ph.D., president and chief executive officer of MeiraGTx. “This will be an important year for MeiraGTx as the Company prepares for the initiation of two Phase 3 pivotal trials in X-linked retinitis pigmentosa and RPE65-associated retinal dystrophy, both with material made from our internal cGMP manufacturing facility in London. With COVID-19 restrictions easing, we are on track to complete enrollment in our Phase 1 AQUAx study in grade 2/3 radiation-induced xerostomia this year as well as open our next study of AAV-GAD for Parkinson’s Disease. We are also progressing several of our pre-clinical programs towards INDs in 2022.” As of March 31, 2021, MeiraGTx had cash and cash equivalents of approximately $199.4 million, as well as approximately $12.0 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 mid-2023. Recent Corporate and Clinical Development Highlights AAV-RPGR for the Treatment of X-Linked Retinitis Pigmentosa (XLRP): MeiraGTx and Janssen continue to prepare for initiation of the Phase 3 Lumeos clinical trial.MeiraGTx and Janssen intend to present additional data from the Phase 1/2 clinical trial of X-linked retinitis pigmentosa (MGT009) at medical meetings later this year. AAV-RPE65 for the Treatment of RPE65-associated Retinal Dystrophy: MeiraGTx continues to anticipate initiating a Phase 3 pivotal trial of AAV-RPE65 in the second half of 2021. AAV-AQP1 for the Treatment of Grade 2/3 R...