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Mar 31, 2025
MeiraGTx Q1 2025 Earnings Report
MeiraGTx reported its financial and operational results for the first quarter ended March 31, 2025.
Key Takeaways
MeiraGTx experienced a pivotal quarter with positive interactions with the FDA for its late-stage clinical programs, strengthening its balance sheet through a strategic collaboration with Hologen AI, and progressing towards potential BLA filings. The company reported a net loss of $39.981 million for the quarter.
MeiraGTx announced a strategic collaboration with Hologen AI, including a $200 million upfront cash payment and the formation of a joint venture, Hologen Neuro AI Ltd, with an additional $230 million committed capital.
The FDA granted Regenerative Medicine Advanced Therapy (RMAT) designation for AAV-GAD for the treatment of Parkinson's disease.
MeiraGTx gained alignment with the FDA on the ongoing Phase 2 AQUAx2 study for radiation-induced xerostomia (RIX) to support a potential BLA filing.
The company is preparing for Marketing Authorization Approval (MAA) submission for rAAV8.hRKp.AIPL1 for LCA4 in the U.K. and discussing a similar pathway with the FDA in the US.
Revenue by Segment
Forward Guidance
MeiraGTx plans to initiate a Phase 3 study of AAV-GAD in the second half of 2025 and continues to work with the FDA to expedite program development. The company also intends to initiate first-in-human studies using its riboswitch platform in 2025.
Positive Outlook
- Initiation of a Phase 3 study for AAV-GAD in the second half of 2025.
- Continued collaboration with FDA to expedite AAV-GAD program development.
- Target for completion of enrollment in high dose cohorts for AAV2-hAQP1 study in Q4 2025, with potential BLA filing by end of 2026.
- Preparation for Marketing Authorization Application (MAA) submission for AAV-AIPL1 in the U.K. and discussions for a similar pathway in the US.
- Intention to initiate first-in-human studies using the riboswitch platform in 2025.
Challenges Ahead
- The primary endpoint for the Phase 3 LUMEOS trial of botaretigene sparoparvovec was not met, though it was directionally supportive.
- The company's ability to achieve or maintain profitability is subject to known and unknown risks.
Historical Earnings Impact
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