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uniQure Announces Second Quarter 2020 Financial Results
and Highlights Recent Company Progress
~ Entered into Exclusive Global License Agreement with CSL Behring for Development and Commercialization of uniQure’s Gene Therapy Candidate for Hemophilia B ~
~ Completed First Patient Dosing in Phase I/II Clinical Trial of AMT-130 in Huntington’s Disease ~
Lexington, MA and Amsterdam, the Netherlands, July 30, 2020 — 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 the second quarter of 2020 and highlighted recent progress across its business.
“The first half of 2020 has been extremely productive for uniQure with significant achievements across our clinical-stage programs,” stated Matt Kapusta, chief executive officer at uniQure. “The initiation of patient dosing in our Phase I/II study of AMT-130 marked the first AAV gene therapy for patients with Huntington’s disease to enter the clinic, and we remain highly focused on advancing development of this important program. We also completed the dosing phase of our HOPE-B pivotal study for etranacogene dezaparvovec in patients with hemophilia B and remain on track to present topline data on all patients by the end of 2020 and submit a BLA in 2021.”
“Importantly, in June we announced a landmark global license agreement with CSL Behring to develop and commercialize our hemophilia B gene therapy candidate, with uniQure eligible following regulatory approval to receive more than $2 billion of economics, including upfront cash, milestone, and royalty payments,” he added. “The collaboration ideally positions us to deliver our highly innovative gene therapy to the largest number of hemophilia B patients as quickly as possible, and we expect it will provide an exceptionally strong balance sheet to aggressively expand our pipeline, invest in technology innovation and further scale our manufacturing capabilities.”
Recent Company Progress
|·||Advancing late-stage development of etranacogene dezaparvovec (AMT-061) for the treatment of hemophilia B|
|·||In June 2020, the Company and CSL Behring entered into a licensing agreement providing CSL Behring with exclusive global rights to etranacogene dezaparvovec, the Company’s investigational gene therapy for patients with hemophilia B. Under the terms of the agreement, which is subject first to regulatory review in the United States, Australia and the United Kingdom, the Company will receive a $450 million upfront cash payment and be eligible to receive up to $1.6 billion in payments based on regulatory and commercial milestones. the Company will also be eligible to receive tiered double-digit royalties in a range of up to a low-twenties percentage of net product sales arising from the collaboration. The agreement is one of the largest gene therapy deals announced to date and leverages CSL Behring’s global hematology capabilities and infrastructure to benefit hemophilia B patients around the world.|
|·||The Company continues to conduct the HOPE-B pivotal trial of etranacogene dezaparvovec and remains on track to provide 26-weeks of Factor IX data for all 54 patients before the end of this year.|
The following information was filed by Uniqure N.V. (QURE) on Friday, July 31, 2020 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-Q Quarterly Report statement of earnings and operation as management may choose to highlight particular information in the press release.
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