AMT Provides Business Update for the First Quarter 2010
Therapeutics (EuroNext Amsterdam: AMT), a leader in the field of human gene
therapy, today provides its non-audited business update in compliance with
the EU transparency directive. This report summarizes material events and
AMT’s financial position for the first quarter of 2010.
Q1 2010 Highlights
- EMA starts formal review of Glybera(R) dossier
- Dossier validated by EMA on January 20, 2010
- Day 120 questions from EMA expected second half of May 2010
- Innovation Credit received from Dutch Government for Duchenne Muscular
Dystrophy
- Up to EUR 4 million funding, repayable only on successful
commercialization
- Supports 35% of development costs through to 2013
- Start of Phase I/II Gene Therapy Clinical Trial for Hemophilia B
- First patient dosed
Business Update
AMT’s cash position* on
compared to
first quarter of 2010, amounting to
operational cash flow. AMT employed 85 persons as of
expenses in the first quarter of 2010 were
million
* The Company’s cash position is composed of cash and cash equivalents.
Material events after
On
from the Supervisory Board and
Management Board.
About Amsterdam Molecular Therapeutics
AMT, founded in 1998 and based in
development of human gene based therapies. Using AAV as the delivery vehicle
of choice for therapeutic genes, the company has been able to design and
validate what is probably the first stable and scalable AAV production
platform. This safe and efficacious proprietary platform offers a unique
manufacturing capability which can be applied to a large number of rare
(orphan) diseases that are caused by one faulty gene. Currently, AMT has a
product pipeline with several AAV-based gene therapy products in LPLD,
Hemophilia B, DMD, Acute Intermittent Porphyria and Parkinson’s Disease at
different stages of research or development.
Certain statements in this press release are “forward-looking statements”
including those that refer to management’s plans and expectations for future
operations, prospects and financial condition. Words such as “strategy,”
“expects,” “plans,” “anticipates,” “believes,” “will,” “continues,”
“estimates,” “intends,” “projects,” “goals,” “targets” and other words of
similar meaning are intended to identify such forward-looking statements.
Such statements are based on the current expectations of the management of
Amsterdam Molecular Therapeutics only. Undue reliance should not be placed on
these statements because, by their nature, they are subject to known and
unknown risks and can be affected by factors that are beyond the control of
AMT. Actual results could differ materially from current expectations due to
a number of factors and uncertainties affecting AMT’s business, including,
but not limited to, the timely commencement and success of AMT’s clinical
trials and research endeavors, delays in receiving U.S. Food and Drug
Administration or other regulatory approvals (i.e. EMA, Health Canada),
market acceptance of AMT’s products, effectiveness of AMT’s marketing and
sales efforts, development of competing therapies and/or technologies, the
terms of any future strategic alliances, the need for additional capital, the
inability to obtain, or meet, conditions imposed for required governmental
and regulatory approvals and consents. AMT expressly disclaims any intent or
obligation to update these forward-looking statements except as required by
law. For a more detailed description of the risk factors and uncertainties
affecting AMT, refer to the prospectus of AMT’s initial public offering on
SOURCE Amsterdam Molecular Therapeutics B.V
