MeiraGTx Reports First Quarter 2025 Financial and Operational Results

MeiraGTx Holdings plc, a vertically integrated, clinical-stage genetic medicines company, has released its financial and operational results for the first quarter ended March 31, 2025. The company has made significant strides in its clinical programs and strategic collaborations, which are expected to impact its future growth and market position.

Financial Highlights

For the first quarter of 2025, MeiraGTx reported a net loss attributable to ordinary shareholders of $40.0 million, or $0.51 per share, compared to a net loss of $20.4 million, or $0.32 per share, for the same period in 2024. The company's cash, cash equivalents, and restricted cash stood at $68.6 million as of March 31, 2025, down from $120.3 million a year earlier. Service revenue increased to $1.9 million from $0.7 million in the prior year, driven by progress in process performance qualification (PPQ) services under an asset purchase agreement with Johnson & Johnson Innovative Medicine.

Business and Operational Highlights

MeiraGTx announced a strategic collaboration with Hologen AI, which includes a $200 million upfront payment and the formation of a joint venture, Hologen Neuro AI Ltd, with an additional $230 million in committed capital. This venture aims to expedite the Phase 3 clinical development of AAV-GAD for Parkinson’s disease. The company also received Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA for AAV-GAD for Parkinson’s disease and aligned with the FDA on the Phase 2 AQUAx2 study for AAV-hAQP1 for radiation-induced xerostomia (RIX).

Strategic Initiatives and Corporate Developments

MeiraGTx's strategic collaboration with Hologen AI is a significant development, providing non-dilutive funding and leveraging Hologen’s AI technology to accelerate the AAV-GAD program. The company is also preparing to file for Marketing Authorization Approval (MAA) for rAAV8.hRKp.AIPL1 for LCA4 in the U.K. and is in discussions with the FDA for a similar pathway in the U.S.

Management's Perspective

Dr. Alexandria Forbes, President and CEO of MeiraGTx, highlighted the positive interactions with the FDA and the progress in late-stage clinical programs. She emphasized the importance of the strategic collaboration with Hologen AI in strengthening the company's balance sheet and advancing its clinical programs.

Future Outlook

MeiraGTx plans to initiate a Phase 3 study of AAV-GAD in the second half of 2025 and aims to complete enrollment for the Phase 2 AQUAx2 study by the fourth quarter of 2025. The company is also preparing for potential BLA filings and expedited approvals for its various clinical programs.

SEC Filing: MeiraGTx Holdings plc [ MGTX ] - 8-K - May. 13, 2025