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Mar 31, 2024
uniQure Q1 2024 Earnings Report
uniQure reported financial results for Q1 2024 and highlighted progress across its business.
Key Takeaways
uniQure made progress on key business priorities in Q1 2024, including advancing AMT-130 for Huntington's disease, initiating new clinical trials, and conserving capital. The company is on track to initiate FDA interactions regarding AMT-130 and provide a clinical update from Phase I/II trials in mid-2024. Enrollment for the Fabry disease study is on track to begin in Q2 2024, with SOD1-ALS and MTLE studies expected to begin in Q3.
On track to initiate FDA interaction regarding AMT-130 in Q2 2024 and provide a clinical update from the Phase I/II trials in mid-2024.
Clinical trial initiation for Fabry disease is on track to begin in Q2 2024, followed by refractory mesial temporal lobe epilepsy and SOD1-ALS in Q3 2024.
A comprehensive review of operations and options to reduce expenses is underway and expected to be completed in mid-2024.
Cash, cash equivalents and investment securities are expected to fund operations into the second quarter of 2027.
uniQure
uniQure
uniQure Revenue by Segment
Revenue by Segment
Collaboration Revenue
CapyFin.comContract Manufacturing of HEMGENIX® Revenue
CapyFin.com Forward Guidance
uniQure anticipates several key milestones and activities in the near term, including interactions with the FDA regarding AMT-130, clinical data updates, and the initiation of new clinical trials. The company is also focused on expense reduction and increasing shareholder value.
Positive Outlook
- Initiate interactions with the FDA in Q2 2024 to define the clinical and regulatory pathway for AMT-130.
- Provide an update from ongoing Phase I/II clinical trials of AMT-130 in mid-2024, including up to three years of follow-up data on 29 treated patients.
- Complete enrollment in the third cohort of the AMT-130 clinical trial in the second half of 2024.
- Begin patient enrollment in a Phase I/IIa clinical trial for AMT-191 for Fabry disease in Q2 2024.
- Begin patient enrollment in Phase I/II clinical trials for AMT-162 for SOD1 ALS and AMT-260 for refractory MTLE in Q3 2024.
Challenges Ahead
- Clinical results and the development and timing of the Company’s programs
- Company’s interactions with regulatory authorities, which may affect the initiation, timing and progress of clinical trials and pathways to approval
- Company’s ability to continue to build and maintain the company infrastructure and personnel needed to achieve its goals
- Company’s effectiveness in managing current and future clinical trials and regulatory processes
- Impact of global economic uncertainty, rising inflation, rising interest rates or market disruptions on its business.
Revenue & Expenses
Visualization of income flow from segment revenue to net income