MeiraGTx Announces Third Quarter 2024 Financial and Operational Results
MeiraGTx Holdings plc, a vertically integrated, clinical-stage genetic medicines company, has released its financial and operational results for the third quarter ended September 30, 2024. The company has also provided updates on recent business developments and strategic initiatives.
Financial Highlights
For the third quarter of 2024, MeiraGTx reported a net loss attributable to ordinary shareholders of $39.3 million, or $0.55 per share, compared to a net loss of $44.3 million, or $0.74 per share, for the same period in 2023. The company’s cash and cash equivalents stood at approximately $122.9 million as of September 30, 2024, down from $130.6 million at the end of 2023.
Service revenue for the quarter was $10.9 million, driven by progress in process performance qualification (PPQ) services under the asset purchase agreement with Johnson & Johnson Innovative Medicine. However, there was no license revenue for the quarter, a decrease from $5.1 million in the same period last year due to the termination of the collaboration agreement with Johnson & Johnson.
General and administrative expenses increased to $12.7 million from $10.0 million in the prior year, primarily due to higher legal and accounting fees, payroll costs, and consulting fees. Research and development expenses decreased slightly to $26.2 million from $27.9 million, mainly due to reduced manufacturing costs and a reclassification of service revenue costs.
Business and Operational Highlights
MeiraGTx has made significant strides in its clinical and regulatory efforts. The company received three Rare Pediatric Disease Designations (RPDD) from the FDA for its AAV8-RK-AIPL1, AAV8-RK-BBS10, and AAV5-RDH12 programs, each targeting different inherited retinal diseases. Additionally, the company announced positive data from a randomized, sham-controlled clinical bridging study of AAV-GAD for the treatment of Parkinson’s disease.
Following meetings with the UK Medicines and Healthcare products Regulatory Agency (MHRA), MeiraGTx plans to submit a Marketing Authorization Application (MAA) under exceptional circumstances for AAV-AIPL1 in the UK without further clinical studies. The company is also in discussions with the FDA for a similar pathway in the U.S.
Strategic Initiatives and Corporate Developments
MeiraGTx continues to advance its riboswitch gene regulation technology platform, focusing on obesity, metabolic diseases, and CAR-T for oncology and autoimmune diseases. The company is also progressing its Phase 2 AQUAx2 clinical trial for the treatment of xerostomia and expects data from the Phase 3 LUMEOS trial of botaretigene sparoparvovec (bota-vec) for X-linked retinitis pigmentosa by the end of the year.
Financially, MeiraGTx believes it has sufficient capital to fund operations into the second quarter of 2026, supported by anticipated milestones from Johnson & Johnson Innovative Medicine and other financial resources.
Management's Perspective
Dr. Alexandria Forbes, President and CEO of MeiraGTx, highlighted the company's recent clinical, regulatory, and research advancements. She emphasized the positive data from the AAV-GAD bridging study for Parkinson’s disease and the RPDD awards for three additional programs. Dr. Forbes also noted the company's strategic efforts to expedite the approval of transformative products for rare pediatric disorders.
Future Outlook
Looking ahead, MeiraGTx plans to continue engaging with global regulatory agencies to advance its clinical programs. The company aims to initiate a Phase 3 registrational study for AAV-GAD and explore expedited approval pathways for its RPDD-awarded indications. Additionally, MeiraGTx intends to initiate first-in-human studies using its riboswitch platform for an undisclosed metabolic disease indication in 2025.
SEC Filing: MeiraGTx Holdings plc [ MGTX ] - 8-K - Nov. 13, 2024