Financial Performance - MeiraGTx reported cash and cash equivalents of approximately $17.1 million as of September 30, 2025, down from $105.7 million as of December 31, 2024[18]. - Service revenue decreased to $0.4 million for Q3 2025, compared to $10.9 million for Q3 2024, a decline of $10.5 million[18]. - For the three months ended September 30, 2025, total revenue was $410,000, a decrease of 96.2% compared to $10.91 million for the same period in 2024[31]. - Net loss attributable to ordinary shareholders for the quarter ended September 30, 2025, was $50.5 million, or $0.62 per share, compared to a net loss of $39.3 million, or $0.55 per share for the same quarter in 2024[26]. - Cash and cash equivalents decreased to $14.8 million as of September 30, 2025, down from $103.7 million as of December 31, 2024[33]. - Total current liabilities increased to $152.9 million as of September 30, 2025, compared to $60.8 million as of December 31, 2024[33]. - The company reported a foreign currency loss of $1.6 million for the three months ended September 30, 2025, compared to a gain of $3.5 million for the same period in 2024, reflecting a change of $5.1 million[24]. - Interest income decreased to $0.2 million for the three months ended September 30, 2025, down from $1.2 million in the same period in 2024, a decline of 83.3%[24]. - Interest expense decreased to $3.1 million for the three months ended September 30, 2025, compared to $3.4 million for the same period in 2024, a reduction of 8.8%[25]. Research and Development - Research and development expenses increased to $32.5 million for Q3 2025, up from $26.2 million in Q3 2024, reflecting higher manufacturing costs and clinical program expenses[22]. - Research and development expenses for the three months ended September 30, 2025, were $32.5 million, an increase of 24.0% from $26.2 million in the same period in 2024[31]. - The pivotal Phase 2 study of AAV-hAQP1 for radiation-induced xerostomia is on track for target enrollment by the end of 2025, with potential BLA filing in early 2027[3]. - The company anticipates initiating a Phase 3 study for AAV-GAD in Parkinson's disease in the coming months, following positive data from previous studies[11]. - The BBS10 program for a rare pediatric ophthalmology condition has been awarded Rare Pediatric Disease Designation, with the first patient treated during the quarter[4]. - MeiraGTx has completed optimization of its riboswitch program for leptin delivery, demonstrating durability and efficacy in a mouse model over more than a year[5]. Strategic Collaborations and Future Prospects - MeiraGTx entered a strategic collaboration with Eli Lilly, receiving an upfront payment of $75 million and potential milestone payments exceeding $400 million[7]. - The company is eligible to receive up to $285 million upon the first commercial sales of botaretigene sparoparvovec in the US and EU[14]. Manufacturing and Technology - The company has developed a novel technology for in vivo delivery of biologic therapeutics using oral small molecules, focusing on metabolic peptides and CAR-T therapies[27]. - MeiraGTx has built comprehensive manufacturing capabilities with five facilities globally, including two licensed for GMP viral vector production[27].
MeiraGTx(MGTX) - 2025 Q3 - Quarterly Results