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Highlights
- Start of the preregistration clinical trial with Glybera(R)
in Canada following two previous clinical trials
- Presentation of additional data indicating that Glybera(R) offers
a clinically important health benefit, accomplished by a significant
and clinically important reduction in the incidence of acute
pancreatitis in patients
- Significant progress in research and development for other
pipeline projects including hemophilia B, Duchenne muscular dystrophy
and Parkinson's disease
- Key financial figures in line with guidance
- Cash & cash equivalents of EUR 25 million at June 30, 2009
Results comparison
AMT's key financial figures are well within the budgets for the first semester and therefore remain in line with the guidance that the company has given for 2009. The operating loss increased to EUR 9.9 million for the six months ended June 30, 2009, from EUR 9.1 million for the same period in 2008. This difference is primarily due to the increase of research & development costs to EUR 7.1 million from EUR 5.8 million in the same period of 2008. This increase is particularly related to the clinical development and regulatory work on the company's lead product, Glybera(R), as well as increased staffing for this and other programs. General and administrative costs decreased to EUR 2.9 million, from EUR 3.3 million in the first half of 2008, primarily as a result of decreased advisor's fees.
The net loss for the half of 2009 was EUR 9.4 million, as compared to a net loss of EUR 8.1 million for the first half of 2008.
At June 30, 2009, AMT's cash and cash equivalents amounted to EUR 25 million, compared to EUR 34 million at December 31, 2008.
"AMT showed important results in the first half of 2009. We presented additional data showing the clinically important health benefit of our lead product, Glybera(R), while good progress was made in the further development of our pipeline-products and the strengthening of the company. The search process for a new permanent CEO is progressing expeditiously but carefully to ensure the engagement of a capable new CEO. All of this reinforces our position as a leader in gene therapy and gives us a strong foundation for further growth," said Sander van Deventer, CEO of AMT.
Conference call and webcast presentation
AMT will conduct a conference call open to the public today at 2.00 p.m. CET, which will also be webcast. Netherlands dial in: +31 800 949 4517 (toll free); US dial in: +1 866 291 4166 (toll free); UK dial in: +44 800 279 3 39 56 (toll free). To listen to the conference call live via the internet, visit the investor relations portion of the AMT website at http://www.amtbiopharma.com. Please go to the website 15 minutes prior to the call to register, download and install the necessary audio software. Playback of the call will be availably for 24 hours after the call. Dial In: +41 91 612 4330; +44 20 7108 6233; or +1 866 416 2558. The archived webcast also will be available for replay shortly after the close of the call.
About Amsterdam Molecular Therapeutics
AMT has a unique gene therapy platform that to date appears to circumvent many if not all of the obstacles that have prevented gene therapy from becoming a mainstay of clinical medicine. Using adeno-associated viral (AAV) vectors 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. As such, AMT's proprietary platform holds tremendous promise, especially for thousands of rare (orphan) diseases that are caused by one faulty gene. Currently, AMT has a product pipeline with nine products at different stages of development.
Accounting policies
Basis of accounting
The condensed interim financial statement for the period ended June 30, 2009 has been prepared in accordance with IAS 34, 'interim financial reporting'. The accounting policies are consistent with those of the annual financial statements for the year ended December 31, 2008, as described in the annual financial statements for the year ended December 31, 2008.
Please refer to our website http://www.amtbiopharma.com for the condensed interim financial report June 30, 2009.
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. EMEA, 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 June 20, 2007, and AMT's public announcements made from time to time.
SOURCE Amsterdam Molecular Therapeutics B.V
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