MeiraGTx Holdings PLC (NASDAQ: MGTX) has announced its financial and operational results for the third quarter ended September 30, 2024. The company reported several significant developments, including receiving three rare pediatric disease designations (RPDD) from the FDA for potential therapies targeting rare inherited retinopathies.
In its financial results, MeiraGTx reported cash, cash equivalents, and restricted cash of $125.0 million as of September 30, 2024, compared to $130.6 million as of December 31, 2023. The company also reported service revenue of $10.9 million for the three months ended September 30, 2024, due to progress in process performance qualification (PPQ) services under the asset purchase agreement and related agreements with Johnson & Johnson Innovative Medicine. This marked a significant increase from the previous period, where there was no license revenue reported for the three months ended September 30, 2024, compared to $5.1 million for the three months ended September 30, 2023.
Cost of service revenue was $12.0 million for the three months ended September 30, 2024, reflecting the progress of PPQ services under the asset purchase agreement and related agreements with Johnson & Johnson Innovative Medicine. Additionally, general and administrative expenses were $12.7 million for the three months ended September 30, 2024, compared to $10.0 million for the three months ended September 30, 2023. This increase was primarily due to higher legal and accounting fees, other office-related costs, payroll and payroll-related costs, and consulting fees, partially offset by a decrease in share-based compensation, rent and facilities costs, and insurance costs.
Furthermore, research and development expenses for the three months ended September 30, 2024 were $26.2 million, compared to $27.9 million for the three months ended September 30, 2023. The decrease in research and development expenses was primarily due to a reduction in manufacturing costs, a decrease in manufacturing material purchases, and a reclassification of cost of service revenue due to the progress of PPQ services provided under the asset purchase agreement and related agreements.
MeiraGTx also highlighted key developments in its pipeline, including positive data from a randomized, sham-controlled clinical bridging study of AAV-GAD for the treatment of Parkinson’s disease, as well as significant advancements in its AAV-AIPL1 program for the treatment of Leber Congenital Amaurosis (LCA4) retinal dystrophy. The company is engaging with global regulatory agencies to initiate a Phase 3 registrational study based on the positive results from the AAV-GAD study and is in discussions with the FDA for the potential approval of AAV-AIPL1 in the United States.
Additionally, the company announced that the FDA has granted RPDD to three of MeiraGTx’s inherited retinal disease programs, which could make them eligible to receive a priority review voucher under the FDA’s rare pediatric disease priority review voucher (PRV) program. MeiraGTx believes that these transformative products for rare and devastating pediatric disorders have the potential to be approved in an expedited fashion, allowing them to rapidly advance potential treatments to severely impacted children.
MeiraGTx also provided an update on its financial position, stating that as of September 30, 2024, it had cash and cash equivalents of approximately $122.9 million, as well as approximately $3.3 million in receivables due from Johnson & Johnson Innovative Medicine. The company believes that with these funds, as well as anticipated near-term milestones from Johnson & Johnson Innovative Medicine under the asset purchase agreement, together with the tax incentive receivable, it will have sufficient capital to fund operating expenses and capital expenditure requirements into the second quarter of 2026.
The market has reacted to these announcements by moving the company's shares 4.5% to a price of $6.96. For the full picture, make sure to review MeiraGTx's 8-K report.
