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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

 

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

 

Date of Report (Date of earliest event reported): August 20, 2019

 

uniQure N.V.

(Exact Name of Registrant as Specified in Charter)

 

The Netherlands   001-36294   N/A
(State or Other
Jurisdiction of Incorporation)
  (Commission
File Number)
  (IRS Employer
Identification No.)

 

Paasheuvelweg 25a,
1105 BP Amsterdam, The Netherlands
  N/A
(Address of Principal Executive Offices)   (Zip Code)

 

Registrant’s telephone number, including area code: +31-20-566-7394

 

 

(Former Name or Former Address, if Changed Since Last Report)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

 

¨       Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

¨       Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

¨       Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

¨       Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class:   Trading Symbol(s)   Name of each exchange on which registered:
Ordinary Shares, par value €0.05 per share   QURE   The Nasdaq Global Select Market

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

 

Emerging growth company ¨

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨

 

 

 

 

 

 

Item 5.02 Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers

 

Effective August 20, 2019, uniQure N.V. (the “Company”) promoted Alex Kuta, Ph.D. to Executive Vice President, Operations and Sander van Deventer, M.D., Ph.D. to Executive Vice President, Research and Product Development (such promotions are collectively referred to herein as the “Leadership Promotions”). In connection with the Leadership Promotions, the Company eliminated the position of chief operating officer. As a result, Scott McMillan, Ph.D., the Company’s current chief operating officer, will be retiring from the Company, effective as of August 31, 2019. In connection with the Leadership Promotions the Company expects to execute new employment agreements with Dr. Kuta and Dr. van Deventer and a separation agreement with Dr. McMillan.

 

Item 7.01 Regulation FD Disclosure

 

On August 20, 2019, the Company issued a press release regarding the Leadership Promotion. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K.

 

The information furnished pursuant to this Item 7.01, including Exhibit 99.1, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) or otherwise subject to the liabilities under that Section and shall not be deemed to be incorporated by reference into any filing of the Company under the Securities Act of 1933 or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.

 

Item 9.01 Financial Statements and Exhibits

 

(d)       Exhibit

 

Exhibit No.   Description
     
99.1   Press Release of uniQure N.V. dated August 20, 2019 announcing the Leadership Promotions
104   Cover Page formatted in Inline XBRL.

 

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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: August 26, 2019 By: /S/ MATTHEW KAPUSTA
    Matthew Kapusta
    Chief Executive Officer and Chief Financial Officer

 

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Exhibit 99.1

 

 

 

uniQure Announces Leadership Promotions and Executive Transition

 

Lexington, MA and Amsterdam, the Netherlands, August 20, 2019 — uniQure N.V. (NASDAQ: QURE), a leading gene therapy company advancing transformative therapies for patients with severe medical needs, today announced the promotions of Sander van Deventer, M.D., Ph.D., to Executive Vice President, Research and Product Development, and Alex Kuta, Ph.D., to Executive Vice President, Operations, effective immediately. As a result of these changes, the Company is eliminating the Chief Operating Officer role, and Scott McMillan, Ph.D., will be retiring from uniQure.

 

“With the promotions of Sander and Alex, we are recognizing the demonstrated track-records and exceptional leadership that each has provided as we advance uniQure’s pipeline of novel gene therapies,” stated Matt Kapusta, chief executive officer of uniQure. “As an original founder of uniQure, Sander is a renowned industry expert who has developed an exceptional research team and expanded our proprietary pipeline of investigational AAV gene therapies. Alex has spearheaded and achieved remarkable regulatory successes for our hemophilia and Huntington’s disease programs. We very much look forward to their continued contributions as we progress AMT-061 for the treatment of hemophilia B towards our planned regulatory submissions and expect to advance AMT-130 into the clinic for the treatment of Huntington’s disease. I also would like to thank Scott for his important contributions to uniQure over the past two years. Scott has played an important role in significantly strengthening our industry-leading CMC capabilities, and I wish him all the best in the future.”

 

In Dr. van Deventer’s new role as Executive Vice President, Research and Product Development, he is responsible for the Company’s gene therapy research activities, as well as nonclinical development, process development, analytical development and vector development. Dr. van Deventer will continue to serve as General Manager of uniQure’s Amsterdam research and technology center of excellence. In Dr. Kuta’s new role as Executive Vice President, Operations, he is responsible for global quality and regulatory affairs, as well as GMP manufacturing at uniQure’s state-of-the-art facility in Lexington, Massachusetts.

 

Dr. van Deventer joined uniQure as Chief Scientific Officer and General Manager, Amsterdam in August 2017 and is a leading pioneer in the biotechnology industry and in the field of gene therapy. He was a co-founder of uniQure's predecessor Amsterdam Molecular Therapeutics (AMT) in 1998 and previously served on uniQure’s board of directors. Dr. van Deventer is currently Operating Partner at Forbion Capital partners and Professor of Translational Gastroenterology at Leiden University Medical Center. He also serves as member of the Board for Hookipa Pharma Inc. in Vienna, Austria. Dr. van Deventer is a trained internist and board-certified gastroenterologist. He received a Ph.D. from the University of Amsterdam.

 

Dr. Kuta joined uniQure in January 2017 as Senior Vice President, Regulatory Affairs with more than 30 years in the biotechnology field. His previous experiences include senior roles at EMD Serono, AMAG Pharmaceuticals and Genzyme Corporation, where Dr. Kuta served for 15 years in regulatory leadership positions of increasing responsibility. Prior to joining industry, he was Chief of the Cytokine and Gene Therapy Branch in the Center for Biologics at FDA. Dr. Kuta has also served as a member of the BIO Regulatory Affairs Leadership Committee, Cell and Gene Therapy Working Group and the ICH Gene Therapy Working Group. Dr. Kuta holds a Bachelor of Science degree from Saint John's University and a Ph.D. from Chicago Medical School at Rosalind Franklin U-Med & Science. He conducted his post-doctoral studies at the National Cancer Institute/ National Institutes of Health.

 

 

 

 

About uniQure

 

uniQure is delivering on the promise of gene therapy – single treatments with potentially curative results. We are leveraging our modular and validated technology platform to rapidly advance a pipeline of proprietary gene therapies to treat patients with hemophilia B, hemophilia A, Huntington's disease, Fabry disease, spinocerebellar ataxia Type 3 and other diseases. www.uniQure.com

 

uniQure Forward-Looking Statements

 

This press release contains forward-looking statements. All statements other than statements of historical fact are forward-looking statements, which are often indicated by terms such as "anticipate," "believe," "could," "estimate," "expect," "goal," "intend," "look forward to", "may," "plan," "potential," "predict," "project," "should," "will," "would" and similar expressions. Forward-looking statements are based on management's beliefs and assumptions and on information available to management only as of the date of this press release. These forward-looking statements include, but are not limited to, our ability to file any planned regulatory submissions for AMT-061 or any product, our ability to advance AMT-130 into the clinic for the treatment of Huntington’s disease, our ability to achieve any of our other planned near term or other milestones, the risk of cessation, delay or lack of success of any of our ongoing or planned clinical studies, and/or the development and regulatory approval of our product candidates. Our actual results could differ materially from those anticipated in these forward-looking statements for many reasons, including, without limitation, risks associated with our and our collaborators’ clinical development activities, clinical results, collaboration arrangements, corporate reorganizations and strategic shifts, regulatory oversight, product commercialization and intellectual property claims, as well as the risks, uncertainties and other factors described under the heading "Risk Factors" in uniQure’s Quarterly Report on Form 10-Q filed on July 29, 2019. Given these risks, uncertainties and other factors, you should not place undue reliance on these forward-looking statements, and we assume no obligation to update these forward-looking statements, even if new information becomes available in the future.

 

uniQure Contacts:

 

FOR INVESTORS:       FOR MEDIA:
         
Maria E. Cantor   Eva M. Mulder   Tom Malone
Direct: 339-970-7536   Direct: +31 20 240 6103   Direct: 339-970-7558
Mobile: 617-680-9452   Mobile: +31 6 52 33 15 79   Mobile:339-223-8541
m.canto@uniQure.com   e.mulder@uniQure.com   t.malone@uniQure.com

 

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