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Sep 30, 2024
MeiraGTx Q3 2024 Earnings Report
MeiraGTx's financial and operational performance for Q3 2024 was announced, featuring advancements in clinical trials and regulatory designations.
Key Takeaways
MeiraGTx reported a net loss of $39.3 million for Q3 2024, with service revenue from related parties at $10.9 million. The company highlighted clinical advancements, including positive data from the AAV-GAD bridging study for Parkinson's disease and three Rare Pediatric Disease Designations from the FDA.
Received 3 Rare Pediatric Disease Designations (RPDD) from FDA for potential therapies.
Agreed on pathway with MHRA for Marketing Authorization Application (MAA) for AAV-AIPL1.
Announced positive data from randomized, sham-controlled clinical bridging study of AAV-GAD for Parkinson’s disease.
Cash and cash equivalents totaled $122.9 million as of September 30, 2024.
Revenue by Segment
Forward Guidance
MeiraGTx anticipates several milestones, including data from the Phase 3 LUMEOS trial of botaretigene sparoparvovec and initiation of first in human studies using the riboswitch platform for an undisclosed metabolic disease indication in 2025.
Positive Outlook
- Data from the Phase 3 LUMEOS trial of botaretigene sparoparvovec is expected towards the end of this year.
- Eligible to receive up to $285 million upon the first commercial sales of bota-vec in the U.S. and EU and manufacturing tech transfer.
- Entered into a commercial supply agreement with Johnson & Johnson Innovative Medicine for bota-vec manufacturing.
- Continue to progress its riboswitch technology platform in multiple potential indications.
- Intends to initiate first in human studies using the riboswitch platform for an undisclosed metabolic disease indication in 2025.
Challenges Ahead
- Incurrence of significant losses.
- Inability to achieve or maintain profitability.
- Failure to raise additional capital.
Historical Earnings Impact
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Avg. Return Before/After Earnings
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