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uniQure Announces 2017 Financial Results and Recent Company Progress
~ On Track to Begin Pivotal Study of AMT-061 in Hemophilia B in Q3 2018
~ Submitted IND Amendment for AMT-061 Dose Confirmation Study, with Topline Data Expected by End of 2018
~ Expects IND Submission for AMT-130 in Huntingtons Disease in the Second Half of 2018
~ $159 million of cash and cash equivalents as of December 31, 2017
Lexington, MA and Amsterdam, the Netherlands, March 14, 2018 uniQure N.V. (NASDAQ: QURE), a leading gene therapy company advancing transformative therapies for patients with severe medical needs, today reported its financial results for 2017 and highlighted recent progress across its business.
We ended 2017 with significant momentum across all of our gene therapy programs, and a strong cash position to fund our business into 2020, stated Matthew Kapusta, chief executive officer of uniQure. We remain highly focused on initiating our pivotal study for AMT-061 in hemophilia B and advancing AMT-130 into a Phase I/II study in Huntingtons disease. We look forward to providing updates on our progress throughout the year, including the presentation of top-line clinical data on AMT-061 by year-end.
Recent Company Progress:
· Advancing AMT-061 for the treatment of hemophilia B into a pivotal trial
· In the first quarter of 2018, the Company submitted an Investigational New Drug (IND) amendment to the U.S. Food and Drug Administration (FDA) supporting its planned AMT-061 dose-confirmation study. Extensive data including comparability, manufacturing capability and non-clinical safety and bioequivalence were included in the submission. The Company anticipates initiating the treatment of patients early in the third quarter of 2018 at a single dose of 2 x 10(13) gc/kg. Top line data from these patients are expected to be presented by the end of the year.
· The process of site selection for the pivotal phase III study has been initiated and reviews by institutional review boards (IRB) are underway. The Company expects to begin patient enrollment in the lead-in phase of the pivotal study in the third quarter of 2018.
· In the first quarter of 2018, the Company completed the full comparability analysis for AMT-061, which the Company believes continues to support the comparability between AMT-060 and AMT-061.
· The Company has completed the manufacturing and full quality release of product for use in the dose confirmation study. The product was produced in the Companys state-of-the-art manufacturing facility in Lexington, Massachusetts.
· The European Medicines Agency (EMA) issued a positive opinion on Orphan Drug Designation for AMT-061 in hemophilia B.
· Advancing AMT-130 for the treatment of Huntingtons disease into a Phase I/II study
· Preclinical data presented at the 13th Annual Huntingtons Disease Therapeutics Conference in Palm Springs, CA demonstrated that knocking down human mutant huntingtin (mHTT) by AMT-130 was safe and well-tolerated in both the deep structure of the striatum and the cortex when
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Recognized $2.5 million of license revenue during the three months ended March 31, 2018 related to the collaboration with BMS compared to $1.1 million that would have been recognized in accordance with the previous revenue recognition policies
Our 2018 costs decreased by $0.3 million as a result of a restructuring implemented in the beginning of 2017
The decrease was primarily due to the nonrecurring costs we incurred in 2017 related to our conversion from a foreign private issuer to a U.S. domestic filer.
Our costs in 2018 decreased as a result of consolidating our facilities in Amsterdam into one new facility in April 2017 and
The increase in license revenue is a consequence of the method we use to determine the amount of services rendered.
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Ticker: QURE
CIK: 1590560
Form Type: 10-Q Quarterly Report
Accession Number: 0001558370-18-003530
Submitted to the SEC: Mon Apr 30 2018 4:18:11 PM EST
Accepted by the SEC: Mon Apr 30 2018
Period: Saturday, March 31, 2018
Industry: Pharmaceutical Preparations