NASDAQ$MGTX
MeiraGTx Holdings plc · Q1 2025 earnings
Q1 2025 earnings · · Before market open · Investor relations
Briefing
MeiraGTx reported its financial and operational results for the first quarter ended March 31, 2025.
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.
Headline financials
Revenue & EPS history
MeiraGTx · Revenue · Quarterly
$1.93M
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.
Tailwinds
- 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.
Headwinds
- 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.
- Potential for failure to obtain FDA or other regulatory approval for product candidates within expected time frames or at all.
- Risks associated with the impact of pandemics, epidemics, or infectious diseases on clinical trials and business operations.
- The company's ability to repay its debt obligations and identify additional product candidates is subject to various risks.
Historical earnings impact
How earnings announcements have historically affected this stock's price.
Avg. return before/after earnings
Based on 18 quarterly earnings reports · overlaid with Q1 2025
+0.1%
Avg return
Earnings day
-0.3%
Avg return
5 days after
-0.0%
Avg return
30 days after
31%
10 / 32 earnings
Positive
+25.0%
Q1 2019
Best reaction
-20.4%
Q4 2019
Worst reaction
| Quarter | Report date | Reaction (Day 0) | +5 days | +30 days |
|---|---|---|---|---|
| Q4 2025 | -2.0% | -6.1% | — | |
| Q1 2026 | -0.2% | -8.4% | -3.7% | |
| Q3 2025 | -4.5% | -10.5% | +3.0% | |
| Q2 2025 | -0.1% | -9.1% | -8.8% | |
| Q1 2025 | -0.4% | +5.2% | +31.5% | |
| Q4 2024 | +1.3% | +17.0% | -18.9% | |
| Q3 2024 | -0.3% | -8.6% | -8.1% | |
| Q2 2024 | -3.4% | -3.2% | -4.8% | |
| Q1 2024 | -1.4% | +1.8% | -7.2% | |
| Q4 2023 | +0.0% | -1.1% | -12.4% | |
| Q3 2023 | +4.7% | +19.2% | -1.3% | |
| Q2 2023 | +5.6% | +1.6% | -3.8% | |
| Q1 2023 | -6.9% | +12.9% | +30.2% | |
| Q4 2022 | -3.4% | -11.9% | -8.3% | |
| Q3 2022 | -7.3% | -6.3% | -13.2% | |
| Q2 2022 | +14.4% | +7.0% | -5.9% | |
| Q1 2022 | -3.1% | -5.9% | -15.0% | |
| Q4 2021 | -2.4% | -5.0% | -7.1% | |
| Q3 2021 | -1.7% | -1.7% | +1.8% | |
| Q2 2021 | -0.9% | -8.3% | -16.2% | |
| Q1 2021 | -2.4% | -3.7% | +10.2% | |
| Q4 2020 | +8.0% | +9.1% | -17.3% | |
| Q3 2020 | -1.7% | +4.1% | -6.9% | |
| Q2 2020 | +5.1% | +5.6% | -3.7% | |
| Q1 2020 | +7.8% | +16.1% | +8.0% | |
| Q4 2019 | -20.4% | -38.8% | -11.1% | |
| Q3 2019 | +1.7% | +6.7% | +49.4% | |
| Q2 2019 | -10.6% | -15.2% | -22.9% | |
| Q1 2019 | +25.0% | +32.1% | +23.5% | |
| Q4 2018 | -3.0% | -3.7% | +3.4% | |
| Q3 2018 | -2.6% | -5.3% | -5.5% | |
| Q2 2018 | +7.9% | +6.2% | +40.7% | |
| Q1 2018 | — | — | — | |
| Q4 2017 | — | — | — | |
| Q3 2017 | — | — | — | |
| Q2 2017 | — | — | — | |
| Q1 2017 | — | — | — |
Discussion
Share your read of this quarter. Sign-in carries your eToro identity.
Join the conversation
Sign in with eToro to post your read of this quarter and vote on others'.
Sign in with eToro