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Form 6-K Prosensa Holding N.V. For: Nov 17

November 17, 2014 7:01 AM
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 6-K

REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934

For the month of November 2014.

Commission File Number: 001-35990

Prosensa Holding N.V.
(Translation of registrant's name into English)

J.H. Oortweg 21
2333 CH Leiden
The Netherlands

(Address of principal executive office)

Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.
Form 20-F [ x ] �����Form 40-F [ �]

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ������

Note: Regulation S-T Rule 101(b)(1) only permits the submission in paper of a Form 6-K if submitted solely to provide an attached annual report to security holders.

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ������

Note: Regulation S-T Rule 101(b)(7) only permits the submission in paper of a Form 6-K if submitted to furnish a report or other document that the registrant foreign private issuer must furnish and make public under the laws of the jurisdiction in which the registrant is incorporated, domiciled or legally organized (the registrant's "home country"), or under the rules of the home country exchange on which the registrant's securities are traded, as long as the report or other document is not a press release, is not required to be and has not been distributed to the registrant's security holders, and, if discussing a material event, has already been the subject of a Form 6-K submission or other Commission filing on EDGAR.


On November 17, 2014 the Registrant issued a press release, a copy of which is attached hereto as Exhibit 99.1 and is incorporated herein by reference.


(c) � � Exhibit 99.1. Press release dated November 17, 2014


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.

Prosensa Holding N.V.
(Registrant)

Date: November 17, 2014 /s/ BERNDT MODIG
Berndt Modig
CFO

EXHIBIT 99.1

Prosensa Announces 3rd Quarter 2014 Financial Results and Recent Corporate Developments

LEIDEN, The Netherlands, Nov. 17, 2014 (GLOBE NEWSWIRE) -- Prosensa Holding N.V. (Nasdaq: RNA), the biopharmaceutical company focusing on RNA-modulating therapeutics for rare diseases with high unmet need, today reported financial results for the third quarter ending September 30, 2014 and provided an update on the regulatory plans and re-dosing for drisapersen, our lead exon-skipping drug candidate, and next steps for our follow-on exon skipping compounds for the treatment of Duchenne muscular dystrophy (DMD).

Hans Schikan, CEO of Prosensa said, "We are incredibly pleased with the substantial progress we have accomplished during this period. We have delivered on our promise of initiating the re-dosing process for patients who were previously in drisapersen clinical trials with a total of 15 boys now back on treatment, and our rolling New Drug Application (NDA) submission with the US Food & Drug Administration (FDA) is currently well underway. We continue to work as diligently and quickly as possible to fulfill our promise of bringing much needed therapies to boys with DMD."

Recent Corporate Highlights

Drisapersen Development Program

Publications & Scientific Presentations

Financial Highlights

2014 Guidance

Conference Call / Webcast Information

Prosensa will host a conference call on November 17, 2014 at 8:00 a.m. US Eastern Time, 2:00 p.m. Central European Time, to discuss the third quarter financial results and provide a corporate update. In order to participate in the conference call, please dial +1-877-407-9170 (US domestic toll-free). International dial-in numbers and an audio webcast can be accessed under "Events & Presentations" through the Investors & Media section of the Prosensa corporate website at www.prosensa.com.

About Prosensa Holding N.V.

Prosensa (Nasdaq: RNA) is a biotechnology company engaged in the discovery and development of RNA-modulating therapeutics for the treatment of genetic disorders. Its primary focus is on rare neuromuscular and neurodegenerative disorders with a large unmet medical need, including Duchenne muscular dystrophy (DMD), myotonic dystrophy and Huntington's disease.

Prosensa's current portfolio includes six compounds for the treatment of DMD, all of which have received orphan drug designation in the United States and the European Union. The compounds use an innovative technique called exon-skipping to provide a personalized medicine approach to treat different populations of DMD patients. www.prosensa.com

About DMD

DMD is one of the most prevalent rare genetic diseases globally affecting up to 1 in 3,500 boys and is invariably fatal. There is currently no approved disease-modifying therapy for DMD. The progressive muscle-wasting that characterizes this disease is caused by inadequate production of dystrophin, a protein necessary for muscle function, as a result of mutations in the dystrophin gene. The different mutations, which are mostly deletions of one or more exons, found in the dystrophin gene result in distinct sub-populations of DMD patients.

Forward Looking Statement

This press release contains certain forward-looking statements. All statements, other than statements of historical facts, contained in this press release, including statements regarding the Company's strategy, future operations, future financial position, future revenues, projected costs, prospects, plans and objectives of management, are forward-looking statements. The words "anticipate," "believe," "estimate," "expect," "intend," "may," "plan," "predict," "project," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Forward-looking statements in this press release include statements around the Company's exon-skipping drug pipeline, regulatory review of its product candidates, its intellectual property position and its financial position. Actual results may differ materially from those projected or implied in such forward-looking statements. Such forward-looking information involves risks and uncertainties that could significantly affect expected results. These risks and uncertainties are discussed in the Company's SEC filings, including, but not limited to, the Company's Form 6-K's and the Company's Annual Report on Form 20-F. In addition, any forward-looking statements represent the Company's views only as of today and should not be relied upon as representing its views as of any subsequent date. While the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so, even if its views change.

CONDENSED CONSOLIDATED STATEMENT OF COMPREHENSIVE INCOME (UNAUDITED)
Three months ended September 30, Nine months ended September 30,
2014 2013 2014 2013
� ('000 except per share data)
License revenue� �--� �1,319 �14,695 �4,012
Collaboration revenue� �--� �1,060 �60 �2,751
Total revenue �--� �2,379 �14,755 �6,763
Other income� �250 �186 �702 �220
Research and development expense� �(8,395) �(4,919) �(19,191) �(13,528)
General and administrative expense� �(2,403) �(1,939) �(7,554) �(5,808)
Other gains - net� �26 �11 �122 �19
Operating loss �(10,522) �(4,282) �(11,166) �(12,334)
Finance income� �177 �166 �633 �458
Finance costs� �(304) �(177) �(787) �(576)
Finance cost  net �(127) �(11) �(154) �(118)
Net loss �(10,649) �(4,293) �(11,320) �(12,452)
Other comprehensive income� �--� �--� �--� �--�
Total comprehensive loss* �(10,649) �(4,293) �(11,320) �(12,452)
Loss per share from operations attributable to the equity holders of the Company during the period (in � per share)
Basic and diluted loss per share �(0.29) �(0.12) �(0.31) �(0.40)
* Total comprehensive loss is fully attributable to equity holders of the company
BALANCE SHEET HIGHLIGHTS (UNAUDITED)
� ('000)� As of September 30, As of December 31,
2014 2013
Cash and cash equivalents� �61,984 �82,232
Total assets� �70,361 �90,790
Total equity� �53,495 �63,210
Total liabilities� �16,866 �27,580
CONTACT: Prosensa Holding N.V.
         
         Celia Economides, Senior Director IR &
         Corporate Communications
         Phone: +1 917 941 9059
         Email: [email protected]

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