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Jorn Aldag, Chief Executive Officer of AMT, commented: "In 2009 weannounced a rebalancing of our strategy, focused on our lead productGlybera(R), a proprietary product for lipoprotein lipase deficiency (LPLD),together with the ongoing development of four earlier stage progamstargeting: Hemophilia B, Duchenne Muscular Dystrophy (DMD), AcuteIntermittent Porphyria (AIP) and Parkinson's Disease. At the end of 2009 wereached a major milestone by submitting the Marketing AuthorisationApplication (MAA) for Glybera(R) to the European Medicine Agency (EMA), andthis dossier was validated by EMA on January 20, 2010. After having de-riskedour business model and secured funding into 2011 we are well positioned forthe future."
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Operations
Glybera(R)'s entry into the European registration process is a majormilestone. For a large number of serious diseases, therapeutic options arelimited to providing symptomatic relief at best. Millions of patients have torely on continuous medical care to help them manage their life-longcomplaints. Today, researchers are finally pointing to a number of inspiringsuccesses in gene therapy that carry the excitement of possible cure. Throughgene therapy, the body's lack of natural function is restored thus providinga real, longterm solution. Glybera(R) could be the first gene therapy productto treat a genetic disease to be approved for sale in Europe. AMT expects itssecond gene therapy product to enter clinical development shortly.
Because AMT's technology can be applied equally to a wide range of othergenetic diseases, the success of Glybera(R) would validate AMT's approach forits other pipeline products, targeting a range of orphan and major diseases,including Parkinson's Disease, Hemophilia, DMD and AIP.
The Group appointed a new corporate leadership team. In September 2009,AMT announced that Jorn Aldag had been appointed Chief Executive Officer. InDecember AMT further announced that Piers Morgan had been appointed ChiefFinancial Officer and Hans Preusting had taken up the responsibility forOperations & Project Management. The new team has de-risked our businessmodel through the focus on key projects and a balanced partnering strategy.And, as a first result, we secured further financing to fund the Company into2011.
Results
AMT's operating loss reduced slightly to EUR 17.8 million for 2009, fromEUR 18.8 million for 2008. Research and development expenditure wasmaintained at EUR 13.2 million compared to EUR 13.1 million in 2008, and themodest decrease in operating expenses is primarily due to the decrease ofgeneral and administrative costs to EUR 4.9 million, from EUR 5.9 million in2008. This decrease reflected the higher than normal cost of advisory fees in2008 which did not recur to the same level in 2009. Interest receivable fellto EUR 0.6 million compared to EUR 1.9 million in 2009, reflecting the loweraverage cash balances of the Group during 2009. Consequently the net loss for2009 was EUR 17.2 million, broadly in line with the net loss of EUR 16.9million for 2008.
In December 2009 AMT successfully raised EUR 5 million of new funds via aprivate placement of convertible bonds. The five-year unsecured andunsubordinated bonds, which have a minimum denomination of EUR 100,000, hadan issue price of 100% and pay an annual coupon of 5%. During the conversionperiod the bonds are convertible into ordinary shares of AMT at an initialconversion price of EUR 3.91 or a 30% premium over the then prevailing shareprice.
As of December 31, 2009, AMT had cash and cash equivalents of EUR 22.6million, compared to EUR 34.2 million at December 31, 2008. The net cash burnfor the year amounted to EUR 11.5 million.
Subsequent events
On January 6, 2010 AMT announced that it will receive an InnovationCredit of up to EUR 4 million from the Dutch government to support thedevelopment of AMT's gene therapy treatment for Duchenne Muscular Dystrophy(DMD) The credit is granted by SenterNovem and will fund 35% of the programcosts during the period to mid-2013.
About Amsterdam Molecular Therapeutics
AMT, founded in 1998 and based in Amsterdam, is a leader in thedevelopment of human gene based therapies. Using adeno-associated viral (AAV)vectors as the delivery vehicle of choice for therapeutic genes, the companyhas been able to design and validate what is probably the first stable andscalable AAV production platform. This safe and efficacious proprietaryplatform offers a unique manufacturing capability which can be applied to alarge number of rare (orphan) diseases that are caused by one faulty gene.Currently, AMT has a product pipeline with several AAV-based gene therapyproducts in LPL Deficiency, Hemophilia B, Duchenne Muscular Dystrophy, AcuteIntermittent Porphyria and Parkinson's Disease at different stages ofresearch or development.
Certain statements in this press release are "forward-looking statements"including those that refer to management's plans and expectations for futureoperations, prospects and financial condition. Words such as "strategy,""expects," "plans," "anticipates," "believes," "will," "continues,""estimates," "intends," "projects," "goals," "targets" and other words ofsimilar meaning are intended to identify such forward-looking statements.Such statements are based on the current expectations of the management ofAmsterdam Molecular Therapeutics only. Undue reliance should not be placed onthese statements because, by their nature, they are subject to known andunknown risks and can be affected by factors that are beyond the control ofAMT. Actual results could differ materially from current expectations due toa number of factors and uncertainties affecting AMT's business, including,but not limited to, the timely commencement and success of AMT's clinicaltrials and research endeavors, delays in receiving U.S. Food and DrugAdministration or other regulatory approvals (i.e. EMEA, Health Canada),market acceptance of AMT's products, effectiveness of AMT's marketing andsales efforts, development of competing therapies and/or technologies, theterms of any future strategic alliances, the need for additional capital, theinability to obtain, or meet, conditions imposed for required governmentaland regulatory approvals and consents. AMT expressly disclaims any intent orobligation to update these forward-looking statements except as required bylaw. For a more detailed description of the risk factors and uncertaintiesaffecting AMT, refer to the prospectus of AMT's initial public offering onJune 20, 2007, and AMT's public announcements made from time to time.Highlights - Glybera(R) Marketing Authorisation Application submitted to European Medicines Agency (EMA, formerly known as EMEA); - EMA commenced formal review of Glybera(R) dossier on January 20, 2010; - EMA grants orphan drug designation for AMT's Acute Intermittent Porphyria ("AIP") program; - EMA grants orphan drug designation for AMT's Duchenne Muscular Dystrophy ("DMD") program; - SenterNovem awards EUR 4 million investment credit for the development of AMT's DMD program; - Raised EUR 5 million convertible loan notes, which convert into ordinary shares at EUR 3.91 per share; - New management team.
SOURCE Amsterdam Molecular Therapeutics B.V
