MeiraGTx | 10-Q: FY2025 Q3 Revenue Misses Estimate at USD 410 K

Revenue: As of FY2025 Q3, the actual value is USD 410 K, missing the estimate of USD 6.966 M.

EPS: As of FY2025 Q3, the actual value is USD -0.62, missing the estimate of USD -0.49.

EBIT: As of FY2025 Q3, the actual value is USD -43.15 M.

Service Revenue - Related Party: $410,000 for the three months ended September 30, 2025, compared to $10,910,000 for the same period in 2024. The decrease was due to decreased activity of PPQ services under the Asset Purchase Agreement and related agreements as the work was substantially completed as of September 30, 2025.

Cost of Service Revenue - Related Party: $313,000 for the three months ended September 30, 2025, compared to $11,985,000 for the same period in 2024. The decrease was due to decreased activity of PPQ services under the Asset Purchase Agreement and related agreements as the work was substantially completed as of September 30, 2025.
General and Administrative Expenses: $13,616,000 for the three months ended September 30, 2025, compared to $12,723,000 for the same period in 2024. The increase was primarily due to an increase in rent and facilities costs, consulting fees, share-based compensation, and other office-related costs.
Research and Development Expenses: $32,532,000 for the three months ended September 30, 2025, compared to $26,243,000 for the same period in 2024. The increase was primarily due to an increase in manufacturing costs and costs associated with clinical programs for other ocular diseases and preclinical programs for gene regulation.
Net Loss: $50,513,000 for the three months ended September 30, 2025, compared to $39,330,000 for the same period in 2024.

Net Cash Used in Operating Activities: $92,990,000 for the nine months ended September 30, 2025, compared to $81,219,000 for the same period in 2024.
Net Cash Used in Investing Activities: $3,018,000 for the nine months ended September 30, 2025, compared to net cash provided by investing activities of $24,697,000 for the same period in 2024.
Net Cash Provided by Financing Activities: $6,944,000 for the nine months ended September 30, 2025, compared to $50,290,000 for the same period in 2024.

Foreign Currency (Loss) Gain: - $1,558,000 for the three months ended September 30, 2025, compared to $3,463,000 for the same period in 2024.
Interest Income: $161,000 for the three months ended September 30, 2025, compared to $1,189,000 for the same period in 2024.
Interest Expense: - $3,065,000 for the three months ended September 30, 2025, compared to - $3,357,000 for the same period in 2024.

AAV2-hAQP1 for the Treatment of Radiation-Induced Xerostomia: The Phase 2 AQUAx2 study is enrolling the final high dose cohorts at multiple sites in the US, Canada, and the UK, with the target for completion of enrollment at the end of the year, and potential pivotal data read out which could support a BLA filing in early 2027 with potential approval later in the year.
AAV-GAD for the Treatment of Parkinson’s Disease: The FDA granted RMAT designation to AAV-GAD for Parkinson’s disease not adequately controlled with anti-Parkinsonian medications. The company is engaging with sites globally to initiate the Phase 3 study in the coming months.

Strategic Collaboration with Hologen AI: The company has received $50 million of the $200 million in upfront cash consideration, with the remainder expected in the fourth quarter of 2025. The collaboration includes forming a joint venture, Hologen Neuro AI Ltd, with additional funding from Hologen of up to $230 million to finance the development of the AAV-GAD program for Parkinson’s disease.
Lilly Collaboration Agreement: The company will receive an upfront payment of $75 million and is eligible for over $400 million in milestone payments. Lilly will have the right to research, develop, and commercialize products under the agreement at its cost.