DGAP-News: Prosensa Announces Second Quarter 2013 Financial Results and Recent Corporate Developments
(firmenpresse) - Prosensa Holding N.V.
28.08.2013 13:00
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Raised $89.7M With Successful IPO, Providing Substantial Base to Support
Development of Duchenne Muscular Dystrophy Portfolio
LEIDEN, The Netherlands, 2013-08-28 13:00 CEST (GLOBE NEWSWIRE) --
Prosensa Holding N.V. (Nasdaq:RNA), the Dutch biopharmaceutical company
focusing on RNA-modulating therapeutics for rare diseases with high unmet need,
today reported financial results for the quarter ended June 30, 2013.
'We had a transformative second quarter, culminating with our successful IPO at
the end of June, raising $89.7M. On July 3, 2013, the date we received our IPO
proceeds, our cash and cash equivalents amounted to [Eur]94.3 million ($122.2
million), providing a substantial base to support the development of our
portfolio especially our rapidly advancing Duchenne muscular dystrophy (DMD)
product candidates. We were also very pleased with the results of the phase II
DMD114117 double-blind, placebo-controlled study with drisapersen, which we
exclusively licensed to GlaxoSmithKline (GSK). The study, which met its primary
endpoint, was presented by GSK at the Cold Spring Harbor Conference in April
2013,' said Hans Schikan, CEO of Prosensa.
Mr. Schikan continued, 'We look forward to an incredibly busy and exciting
remainder of the year, particularly as phase III data will become available for
drisapersen. To date, more than 300 patients have participated in clinical
studies with drisapersen at more than 50 trial sites in 25 countries. We
believe that drisapersen, which was recently granted 'Breakthrough Therapy
Designation' by the U.S. Food and Drug Administration, may potentially offer
DMD patients with an amenable mutation an important, much-needed treatment
option and we are dedicated to advancing the rest of our portfolio to help
other sub-populations of boys with this devastating neuromuscular disease.'
Prosensa's current portfolio includes six compounds for the treatment of DMD,
all of which have received orphan drug status in the United States and the
European Union. The compounds utilize an innovative technique called
exon-skipping to provide a personalized medicine approach to treat different
populations of DMD patients.
Recent Corporate Highlights
-- Initial Public Offering
Prosensa announced the pricing of its IPO at $13 on June 27, 2013 and the
stock began trading the following day on the NASDAQ Global Market under the
ticker symbol 'RNA'. The IPO of 6.9 million of the company's ordinary
shares closed on July 3, and raised gross proceeds of $89.7 million.
-- Continued Progress with Drisapersen Development
-- On April 11, 2013 GSK presented results for the DMD114117 (DEMAND II)
clinical trial. The primary endpoint in this double-blind,
placebo-controlled, exploratory study was met and a statistically and
clinically meaningful difference of 35 meters in the six-minute walk test
between the continuous dosing regimen of 6mg/kg per week and placebo was
achieved at 24 weeks. On July 31, 2013, summary results from this study
were posted on GSK's Clinical Study Register.
-- On June 27, 2013, GSK announced that the U.S. Food and Drug Administration,
or FDA, had provided notification that drisapersen has been granted
Breakthrough Therapy Designation for the treatment of DMD. Breakthrough
Therapy Designation is an FDA program intended to facilitate and expedite
development and review of new drugs to address unmet medical need in the
treatment of serious or life-threatening conditions.
-- FP7 Grant Awarded for Development of PRO045
On August 1, 2013, Prosensa announced that it is part of a high quality,
pan-European consortium which has been awarded a prestigious Framework
Programme 7 (FP7) research grant of EUR 6 million from the European
Commission to support the ongoing clinical study of Prosensa's third novel
DMD development candidate, PRO045. The project is expected to run for three
years.
-- Supervisory Board Changes
David Mott, General Partner of New Enterprise Associates, was appointed
Chairman of the Supervisory Board upon completion of the IPO. Mr. Mott
joined the Supervisory Board in 2012 and brings over 25 years of experience
in the biotech industry to Prosensa.
Financial Highlights
-- Cash Position and Cash Consumption
Our cash and cash equivalents as of June 30, 2013 were [Eur]30.8 million,
compared to [Eur]40.7 million as of December 31, 2012. Our cash consumption,
excluding cash flows from financing in the first half of 2013 was [Eur]10.5
million.
The IPO proceeds, received on July 3, 2013, after the deduction of
underwriting discounts, amount to [Eur]64.0 million ($83.4 million).
-- Revenue&Deferred Revenue
Revenue was [Eur]2.0 million for the second quarter 2013 and [Eur]4.4 million for
the six months ended June 30, 2013, compared to [Eur]1.2 million and [Eur]3.2
million for the comparable periods in 2012 due to increased license income
of [Eur]0.5 million and collaboration revenue of [Eur]0.3 million for the second
quarter 2013 and increased license income of [Eur]0.5 million and collaboration
revenue of [Eur]0.7 million for the six months ended June 30, 2013.
All of our license revenue and collaboration revenue were generated under
the GSK Agreement.
-- R&D Expense
Research and development expense was [Eur]4.5 million in the second quarter
2013 and [Eur]8.6 million for the six months ended June 30, 2013, compared to
[Eur]2.7 million and [Eur]4.5 million for the comparable periods in 2012. Research
and development expense mainly increased for the second quarter 2013 as
well as for the six months ended June 30, 2013 due to the commencement of
the phase I/II study of PRO045, the preparations for the initiation of the
phase I/II study of PRO053 and higher intellectual property expenses.
-- G&A Expense
General and administrative expense was [Eur]2.1 million in the second quarter
2013 and [Eur]3.9 million for the six months ended June 30, 2013, compared to
[Eur]0.9 million and [Eur]2.0 million for the comparable periods in 2012. The
increase is primarily due to expenses related to the IPO for an amount of
[Eur]0.8 million recorded in the second quarter 2013 and [Eur]1.5 million for the
six months ended June 30, 2013.
-- Net Loss
Net loss for the second quarter 2013 was [Eur]4.7 million in the second quarter
2013 and [Eur]8.2 million for the six months ended June 30, 2013, compared to
[Eur]2.4 million and [Eur]5.1 million for the comparable periods in 2012.
Near-Term News Flow
-- Drisapersen
In the fourth quarter 2013, GSK aims to make available and present
dystrophin results from the DMD114117 (DEMAND II) study as well as results
from the DMD114044 (DEMAND III) and DMD114876 (DEMAND V) studies at
forthcoming scientific meetings.
-- PRO053
In the third quarter 2013, Prosensa anticipates the first patient to be
dosed with PRO053 in the phase I/II safety and dose finding study which is
currently in the recruitment screening phase.
-- PRO044
In the fourth quarter 2013, results from the phase I/II study will be
presented at forthcoming scientific meetings.
Conference Call / Webcast Information
Prosensa will host a conference call on Wednesday, August 28, 2013 at 8:00am
ET, 2:00pm CET to discuss second quarter 2013 financial results. In order to
participate in the conference call, please dial 1-877-249-9037 (US domestic)
and refer to conference ID 6727193. International dial-in numbers and an audio
webcast can be accessed under 'Events&Presentations' through the Investors&Media section of the Prosensa corporate website www.prosensa.com.
About Prosensa Holding N.V.
Prosensa (Nasdaq:RNA) is an innovative biotechnology company engaged in the
discovery and development of ribonucleic acid-modulating, or RNA-modulating,
therapeutics for the treatment of genetic disorders. Our primary focus is on
rare neuromuscular and neurodegenerative disorders with a large unmet medical
need, including Duchenne muscular dystrophy, myotonic dystrophy and
Huntington's disease. Our clinical portfolio of RNA-based product candidates is
focused on the treatment of Duchenne muscular dystrophy, or DMD. Each of our
DMD compounds has been granted orphan drug status in the United States and the
European Union. Our first product candidate, drisapersen, can address a variety
of mutations in the dystrophin gene, such as a deletion of exon 50 or exons 48
to 50.
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. We are designing product candidates to address several
sub-populations using our platform technology.
About exon skipping and RNA modulation
The dystrophin gene is the largest gene in the body, consisting of 79 exons.
Exons are small sequences of genetic code which, via an intermediate step
involving RNA, lead to the assembly of sections of protein. In DMD, when
certain exons are mutated/deleted, the RNA cannot read past the fault. This
prevents the remainder of the exons from being read, resulting in a
non-functional dystrophin protein and the severe symptoms of DMD. RNA-based
therapeutics, specifically antisense oligonucleotides inducing exon skipping,
are currently in development for DMD. These antisense oligonucleotides skip an
exon next to a defective exon and thereby correct the reading frame, enabling
the production of a novel, largely functional dystrophin protein. Prosensa's
exon skipping technology was licensed from Leiden University Medical Center.
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 our 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 our exon-skipping drug pipeline and 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 containing this press release and
certain sections of the Company's Registration Statement on Form F-1. In
addition, any forward-looking statements represent our views only as of today
and should not be relied upon as representing our views as of any subsequent
date. While we may elect to update these forward-looking statements at some
point in the future, we specifically disclaim any obligation to do so, even if
our views change.
CONTACT: Prosensa Holding N.V.
Celia Economides, Director IR&Corporate Communications
Phone: +1 917 941 9059
Email: c.economides(at)prosensa.nl
News Source: NASDAQ OMX
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