Amsterdam Molecular Therapeutics Provides Business Update for the Third Quarter 2011
AMSTERDAM, November 17, 2011 /PRNewswire/ –
Amsterdam Molecular Therapeutics (Euronext: AMT), a leader in the field
of human gene therapy, today provided its non-audited business update in
compliance with the EU transparency directive. This report summarizes
material events and AMT’s financial position for the third quarter of 2011.
3Q 2011 Highlights
- Glybera(R) Marketing Authorisation Application filed for re-examination - Exclusive license signed with National Institutes of Health (NIH) for use of adeno-associated virus serotype 5 (AAV5)-based gene therapy vectors for liver and brain indications - Dr. Carlos R. Camozzi appointed as Chief Medical Officer
CHMP Decision on Glybera and Re-organization
- Glybera Marketing Authorisation Application re-examination: - Committee for Advanced Therapies (CAT), Scientific Advisory Group (SAG) and new Rapporteur/Co-Rapporteur all recommended Glybera approvable under exceptional circumstances - CHMP concluded that there are no significant safety issues with Glybera - CHMP concluded that insufficient evidence of clinical benefit means Glybera is not approvable at this time - AMT will focus development efforts and financial resources on three gene therapy programs: hemophilia B, GDNF and acute intermittent porphyria - Company remains committed to participating in the Sanfilippo B program, which is fully funded by a consortium led by Institut Pasteur - Further investment in and development of Glybera and Duchenne's muscular dystrophy programs suspended - AMT management is working in close consultation with the AMT Works Council to assess the impact of the review on the Company's workforce - Management and board believe that for AMT to remain a viable business it needs to reduce the headcount by 50% to 45 full-time employees
The Company continues partnering discussions with pharma companies. At
this time, AMT anticipates that it may be possible to conclude a partnership
for its hemophilia B program during the first half of 2012, provided that
additional funding can be secured in the meantime. Therefore, AMT is
exploring all options with regard to the business and its financing, with
support from existing shareholders. AMT is also looking at additional
collaborations with academic groups, which would contribute towards the
short-term funding of its GDNF program for up to three indications.
AMT’s cash position* on September 30, 2011 amounted to EUR 3.8 million
compared to EUR 9.1 million on June 30, 2011. The cash outflow in the third
quarter of 2011, EUR 5.3 million compared to EUR 3.4 million in the prior
year, mainly represented operational cash flow impacted by certain
non-recurring items: outstanding debtors at September 30, 2011 included two
amounts totaling EUR 0.7 million which were due to AMT in the third quarter.
In addition, payments to two third parties under an old grant were
triggered, giving rise to a cash outflow of EUR 0.75 million. Adjusting for
these on a pro forma basis, AMT’s cash position would have been EUR 5.25
million, in line with budget, and the third quarter cash outflow would have
been EUR 3.85 million. AMT employed 83 permanent staff as of September 30,
2011. Total expenses in the third quarter of 2011 were EUR 3.7 million
compared to EUR 4.7 million in the same period last year.
*The Company’s cash position is composed of cash and cash equivalents.
Material events after September 30, 2011
Since September 30, 2011, AMT was informed of the outcome of the Glybera
re-examination process and has consequently initiated a reorganization of
the company, in each case as described above. On November 16, 2011, AMT
announced that its hemophilia B program was granted Orphan designation in
the European Union.
About Amsterdam Molecular Therapeutics
AMT is a world leader in the development of human gene based therapies.
AMT has a product pipeline of several gene therapy products in development
for hemophilia B, acute intermittent porphyria, Parkinson’s disease and
SanfilippoB. Using adeno-associated viral (AAV) derived vectors as the
delivery vehicle of choice for therapeutic genes, the company has been able
to design and validate probably the world’s first stable and scalable AAV
manufacturing platform. This proprietary platform can be applied to a large
number of rare (orphan) diseases caused by one faulty gene and allows AMT to
pursue its strategy of focusing on this sector of the industry. AMT was
founded in 1998 and is based in Amsterdam. Further information can be found
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 AMT 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. AMT expressly
disclaims any intent or obligation to update any forward-looking statements
herein except as required by law.
SOURCE Amsterdam Molecular Therapeutics (AMT) B.V