uniQure N.V.

Thank you for standing by. My name is Liz and I'll be your conference operator today. At this time, I would like to welcome everyone to the Unicure first quarter 2026 earnings call. All lines have been placed on mute to prevent any background noise. After the speaker's remarks, there will be a question and answer session. If you would like to ask a question during this time, simply press star followed by the number one on your telephone keypad. If you would like to withdraw your question, press star one again. Thank you. I would now like to turn the call over to Kiara Russo, Senior Director of Investor Relations. Please go ahead.

Good morning, and thank you for joining us for UNICARE's first quarter of 2026 earnings call. Earlier this morning, Unicure released its financial results for the first quarter of 2026, and our press release is available on the Investors and Media section of our website at unicure.com. Our 10Q was also filed with the SEC earlier today. Joining me on the call this morning are Matt Kapisa, Chief Executive Officer, Dr. Waleed Abisab, Chief Medical Officer, Kylie O'Keefe, Chief Customer and Strategy Officer, and Christian Klempt, Chief Financial Officer. After our formal remarks, we'll open the call up for Q&A. Before we begin, please know that we will be making forward-looking statements during this investor call. All statements other than statements of historical fact are forward-looking statements. They are based on management's beliefs and assumptions and on information available to management only as of the date of this conference call. Our actual results could differ materially from those anticipated in these forward-looking statements for many reasons. including, without limitation, the factors described in Unicure's most recent SEC filing. Given these risks, you should not place undue reliance on these forward-looking statements, and we assume no obligation to update these statements, even if new information becomes available in the future. Now, let me introduce Matt Capista, Unicure's CEO.

Thanks, Chiara. Good morning, and thank you for joining us today. During the first quarter of 2026, Unicure remained focused on advancing AMT-130 to patients while continuing to execute across our broader pipeline. Following our Type A meeting with the FDA in January, we acknowledged the agency's feedback and remained focused on engaging constructively to find a feasible path forward. We have since been granted a Type B meeting with the FDA later this quarter where we plan to discuss our proposed statistical analysis plan for the four-year data expected in the third quarter and key elements of a new clinical study. In parallel, we are progressing toward a potential regulatory submission in the United Kingdom. Following a successful pre-submission meeting with the UK MHRA, we are preparing to submit a marketing authorization application in the third quarter based on the three-year data. Taken together, these efforts reflect our commitment to advancing AMT 130 globally with urgency. Beyond Huntington's disease, we continue to make progress across our pipeline. For AMT260 and refractory mesial temporal lobe epilepsy, enrollment in our phase 1, 2A study is on track, and we expect to report data from the first cohort in the second quarter. In Fabry disease, updated data from our AMT191 program showed sustained and dose-dependent increases in alpha-gal A activity, stable lyso-GB3 levels, and the discontinuation of enzyme replacement therapy in 11 patients. supporting the potential of AMT191 as a meaningful treatment option. Regarding AMT162 and SOD1 ALS, we announced our decision to discontinue development following a comprehensive review of the available data, reflecting our disciplined, data-driven approach to capital allocation. Looking ahead, key milestones include our Type B FDA meeting later in the second quarter, clinical update from AMT260 in the second quarter, four-year AMT 130 data analysis in the third quarter and the planned MAA submission for AMT 130 in the UK in the third quarter. We believe these milestones represent important opportunities to advance our programs and demonstrate the potential of our platform. In summary, we are executing with focus, advancing our lead program through important regulatory interactions and managing our strong balance sheet to support our long-term strategy. We remain committed to delivering on the promise of gene therapy for patients and creating durable value for shareholders. With that, I'll turn the call over to Waleed to provide more information on the pipeline. Thank you, Matt.