uniQure(US:QURE)2025-11-10 12:06Financial Performance - uniQure reported a net loss of $80.5 million for Q3 2025, compared to a net loss of $44.4 million in Q3 2024, resulting in a basic and diluted loss per share of $1.38[18] - Revenue for the three months ended September 30, 2025, was $3.7 million, an increase from $2.3 million in the same period in 2024, driven by a $1.5 million increase in license revenues[10] - Total revenues for Q3 2025 were $3.701 million, a 62% increase from $2.287 million in Q3 2024[29] - Net loss for Q3 2025 was $80.529 million, compared to a net loss of $44.378 million in Q3 2024, indicating increased operational costs[29] - The company reported a basic and diluted net loss per ordinary share of $1.38 for Q3 2025, compared to $0.91 for Q3 2024[29] Cash and Assets - As of September 30, 2025, the company held cash, cash equivalents, and current investment securities of $694.2 million, up from $367.5 million as of December 31, 2024, primarily due to $404.2 million raised through public offerings[9] - Cash and cash equivalents as of September 30, 2025, were $597.056 million, significantly up from $158.930 million at the end of 2024[27] - Total assets increased to $888.382 million as of September 30, 2025, compared to $556.536 million at the end of 2024[27] - Total current liabilities rose to $100.632 million in Q3 2025, up from $40.053 million at the end of 2024, indicating increased financial obligations[27] Research and Development - Research and development expenses for Q3 2025 were $34.4 million, an increase from $30.6 million in Q3 2024, largely due to $6.6 million related to the preparation for the Biologics License Application submission for AMT-130[12] - Research and development expenses increased to $34.366 million in Q3 2025, compared to $30.595 million in Q3 2024, reflecting a focus on advancing clinical programs[29] - The pivotal Phase I/II study of AMT-130 for Huntington's disease showed a statistically significant 75% slowing in disease progression at 36 months, meeting the primary endpoint[4] - The key secondary endpoint of Total Functional Capacity (TFC) demonstrated a statistically significant 60% slowing of disease progression compared to an external control[6] - AMT-260 for mesial temporal lobe epilepsy is advancing, with additional clinical data expected in the first half of 2026[4] - AMT-191 for Fabry disease showed a 27- to 208-fold increase in α-Gal A activity in treated patients, with further data expected in the first half of 2026[4] Administrative Expenses - Selling, general and administrative expenses rose to $19.4 million in Q3 2025 from $11.6 million in Q3 2024, primarily due to increased employee-related expenses and professional fees[13] Future Plans - The company plans to urgently interact with the FDA to define next steps for AMT-130 following unexpected feedback during a pre-BLA meeting[3] - The company plans to progress AMT-130 in the U.S. and interact with the FDA regarding its development[23] - The anticipated completion of dosing in a fourth cohort evaluating high-dose AMT-130 is expected before year-end 2025[23] - The company aims to expand the first cohort in the AMT-260 study into mesial temporal lobe epilepsy and initiate a second cohort[23]