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uniQure (QURE) investor relations material
uniQure Q3 2025 earnings summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Q3 2025 earnings summary10 Nov, 2025
Executive summary
Positive topline data from the pivotal Phase I/II study of AMT-130 in Huntington's disease showed significant slowing of disease progression at 36 months, meeting primary and key secondary endpoints, but FDA feedback introduced uncertainty regarding the timing and adequacy of BLA submission.
Multiple clinical programs advanced, including AMT-260 (epilepsy), AMT-191 (Fabry disease), and AMT-162 (ALS), with notable progress and some safety-related enrollment pauses.
The company remains committed to engaging with the FDA and advancing regulatory discussions in the EU and UK.
Raised $323.7 million in net proceeds from a public offering, strengthening cash position to $694.2 million as of September 30, 2025.
Report covers the quarter ended September 30, 2025, highlighting significant clinical, financial, and operational developments.
Financial highlights
Q3 2025 revenue was $3.7 million, up from $2.3 million in Q3 2024, driven by increased license revenues.
Net loss for Q3 2025 was $80.5 million ($1.38 per share), compared to $44.4 million ($0.91 per share) in Q3 2024.
R&D expenses rose to $34.4 million from $30.6 million year-over-year, mainly due to BLA preparation for AMT-130.
SG&A expenses increased to $19.4 million from $11.6 million, reflecting higher employee and professional fees.
Cash, cash equivalents, and investment securities totaled $694.2 million as of September 30, 2025, up from $367.5 million at year-end 2024, bolstered by public offering proceeds.
Outlook and guidance
Cash runway is expected to fund operations into 2029, including ongoing clinical trials and potential commercialization activities.
The company plans to urgently engage with the FDA to clarify the path forward for AMT-130 and expects to receive formal meeting minutes within 30 days.
Updated data for AMT-260 (epilepsy) and AMT-191 (Fabry disease) are expected in the first half of 2026.
Additional funding may be required if regulatory or development timelines change, especially for AMT-130.
The company is preparing for potential launches in the U.S. and exploring opportunities in the EU and UK.
Clarify FDA's BLA data adequacy concerns
What's next for AMT-162 after DLT pause?
Debt tranche conditions given AMT-130 FDA news?
What is the plan to address FDA's AMT-130 concerns?
AMT-162: What is the path forward?
How does AMT-130 delay affect pipeline investment?
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uniQure N.V. is a biotechnology company that develops gene therapies for the treatment of genetic diseases. The company uses viral vector platforms to deliver therapeutic genes to targeted tissues. It focuses on research, clinical development, and manufacturing of gene-based treatments. The company is headquartered in Amsterdam, Netherlands, and its shares are listed on the NASDAQ.
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