MeiraGTx Holdings plc reported its financial and operational results for the third quarter ended September 30, 2024. As of this date, the company held $125.0 million in cash, cash equivalents, and restricted cash. Service revenue for the quarter was $10.9 million, a significant increase from $0 in the same period of 2023, driven by process performance qualification services under the asset purchase agreement with Johnson & Johnson Innovative Medicine.
The net loss attributable to ordinary shareholders for the third quarter of 2024 was $27.8 million, or $0.40 basic and diluted net loss per ordinary share. Research and development expenses for the quarter were $26.2 million, a decrease of $1.6 million compared to Q3 2023, while general and administrative expenses increased by $2.7 million to $12.7 million. The company believes its current funds, along with anticipated near-term milestones from Johnson & Johnson, will provide sufficient capital to fund operating expenses and capital expenditures into the second quarter of 2026.
MeiraGTx announced it received three Rare Pediatric Disease Designations (RPDD) from the FDA for AAV8-RK-AIPL1 for LCA4, AAV8-RK-BBS10 for Bardet-Biedl syndrome, and AAV5-RDH12 for RDH12-associated retinal dystrophy. Additionally, the company agreed with the UK's MHRA on a pathway to submit a Marketing Authorization Application (MAA) under exceptional circumstances for AAV-AIPL1 for LCA4 without further clinical studies, based on meaningful responses observed in all 11 treated children who were blind at birth and gained vision within 6 weeks. These RPDD designations make the company eligible for Priority Review Vouchers upon BLA approval, which have recently sold for $100 million to $158 million.
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