uniQure N.V. Files 8-K Report

TL;DR

uniQure filed an 8-K, check for new disclosures.

AI Summary

On July 9, 2024, uniQure N.V. filed an 8-K report. The filing primarily concerns financial statements and exhibits, along with other events and a Regulation FD disclosure. No specific material events, transactions, or financial figures beyond the filing date and company identification were detailed in the provided excerpt.

Why It Matters

This filing indicates uniQure N.V. is providing updated information to the SEC, which could include material disclosures relevant to investors.

Risk Assessment

Risk Level: low — The provided text is a standard SEC filing header and does not contain specific material events or financial data that would indicate a change in risk.

Key Players & Entities

• uniQure N.V. (company) — Registrant
• 0001558370-24-009696 (filing_id) — Accession Number
• July 9, 2024 (date) — Date of earliest event reported
• Paasheuvelweg 25a (address) — Principal Executive Offices
• Amsterdam (location) — City of Principal Executive Offices
• The Netherlands (location) — Jurisdiction of Incorporation

FAQ

Filing Documents

• qure-20240709x8k.htm (8-K) — 53KB
• qure-20240709xex99d1.htm (EX-99.1) — 50KB
• qure-20240709xex99d1001.jpg (GRAPHIC) — 7KB
• 0001558370-24-009696.txt ( ) — 241KB
• qure-20240709.xsd (EX-101.SCH) — 3KB
• qure-20240709_lab.xml (EX-101.LAB) — 15KB
• qure-20240709_pre.xml (EX-101.PRE) — 10KB
• qure-20240709x8k_htm.xml (XML) — 4KB

01 Regulation FD Disclosure

Item 7.01 Regulation FD Disclosure. On July 9, 2024, uniQure N.V. (the " Company " ) issued a press release announcing updates on its ongoing clinical trials of AMT-130, as described in more detail in Item 8.01 below. The Company also announced that it will host an investor call and webcast beginning at 8:30 a.m. Eastern Time on the same date, during which the Company will discuss these interim updates. A copy of the press release is being furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference. The virtual event can be accessed via the Events and Presentations section of the Company's website at https://www.uniqure.com/investors-media/events-presentations, and will be available for replay for 90 days following the event. The Company's website and any information contained on the website are not incorporated into this Current Report on Form 8-K. The information provided in this Item 7.01, including the accompanying Exhibit 99.1, shall be deemed "furnished" and shall not be deemed "filed" for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the " Exchange Act "), or otherwise subject to the liability of such section, nor shall it be incorporated by reference in any filing made by the Company pursuant to the Securities Act of 1933, as amended (the " Securities Act "), or the Exchange Act, regardless of the general incorporation language of such filing, except to the extent that such filing incorporates by reference any or all of such information by express reference.

01 Other Events

Item 8.01 Other Events. On July 9, 2024, the Company announced updated interim data from its ongoing clinical trials of AMT-130, a one-time administered investigational gene therapy for the treatment of Huntington's disease. The interim data include follow-up data from patients enrolled in the Company's two ongoing multi-center, dose-escalating Phase I/II clinical trials in the U.S. and Europe as of a March 31, 2024 cut-off date. In the U.S. trial, 26 patients with early manifest Huntington's disease were randomized to treatment (6 low-dose patients, 10 high-dose patients) or an imitation (sham) surgical procedure (10 patients). The U.S. trial consists of a blinded 12-month core patient study period followed by an unblinded long-term follow-up period of five years. An additional four control patients crossed over to treatment. In the European trial, 13 patients with early manifest Huntington's disease were enrolled and treated with AMT-130 (6 low-dose patients, 7 high-dose patients). A third cohort of up to 12 patients is currently being enrolled between U.S. and European sites to explore both doses of AMT-130 in combination with immunosuppression. The combined U.S. and European interim data discussed in Item 8.01 of this Current Report on Form 8-K are subject to a March 31, 2024 cut-off date and do not include outcome or biomarker data from the control patients who have crossed over to treatment with AMT-130 following the 12-month core study period. Across both studies, 24-month follow-up data from a total of 21 patients (12 low dose patients, 9 high-dose patients) were available for analysis as of the cut-off date. The Company conducted a post-hoc statistical analysis of clinical outcomes for the 21 treated patients at 24 months compared to a propensity-weighted external control cohort developed in collaboration with the Cure Huntington's Disease Initiative (CHDI) using data from the TRACK-HD, TRACK-ON and PREDICT-HD natural history studies. The external con

Forward-Looking Statements

Forward-Looking Statements This Current Report on Form 8-K contains forward-looking statements within the meaning of Section 27A of the Securities Act and Section 21E of the Exchange Act. All statements other than statements of historical fact are forward-looking statements, which are often indicated by terms such as "anticipate," "believe," "could," "establish," "estimate," "expect," "goal," "intend," "look forward to", "may," "plan," "potential," "predict," "project," "seek," "should," "will," "would" and similar expressions and the negatives of those terms. Forward-looking statements are based on management's beliefs and assumptions and on information available to management only as of the date of this report. Examples of these forward-looking statements include, but are not limited to, statements concerning: the potential clinical and functional effects of AMT-130; the potential for accelerated regulatory pathways; the Company's use of a natural history cohort as a basis for comparison with respect to the efficacy of AMT-130; the Company's enrollment plans with respect to the third cohort studying AMT-130 in combination with immunosuppression; and the utility of NfL in CSF as an effective biomarker and indicator of clinical severity. The Company's actual results could differ materially from those anticipated in these forward-looking statements for many reasons. These risks and uncertainties include, among others: risks related to the Company's Phase I/ll clinical trials of AMT-130, including the risk that such trials will be unable to demonstrate data sufficient to support further clinical development and the risk that interim data from the trials may not be predictive of later data readouts; risks related to the Company's ability to pursue business development efforts with respect to AMT-130; risks related to the Company's interactions with regulatory authorities, which may affect the initiation, timing and progress of clinical trials and pathways to regulato

01 Financial Statements and Exhibits

Item 9.01 Financial Statements and Exhibits. (d) Exhibits. Exhibit No. Description 99.1 Press Release of uniQure N.V. dated July 9, 2024 104 Cover Page Interactive Data File (embedded with the Inline XBRL document).

SIGNATURES

SIGNATURES Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized. UNIQURE N.V. Date: July 9, 2024 By: /s/ Jeannette Potts JEANNETTE POTTS Chief Legal and Compliance Officer

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View this 8-K filing on SEC EDGAR