During the first half of 2009 Santaris Pharma continued to makesatisfactory progress in its research and development programs within miRNA,metabolic disorders and infectious diseases. Key milestones achieved andother events during the quarter are summarized below.
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Development
SPC3649-HCV
SPC3649 is a potent and specific inhibitor of microRNA-122 known to beinvolved in cholesterol metabolism and in hepatitis virus replication in theliver. In April 2009, Santaris Pharma completed a Phase I First-in-Man singledose study of SPC3649 with 60 healthy volunteers and the Company expects topublicize the encouraging results of this study in the 2nd half of the year.An IND regarding a Phase I multiple dose clinical study with SPC3649 inhealthy volunteers has been submitted and the trial is scheduled to becommenced later in 2009. Further a three months tox study will be initiatedduring the 2nd half of 2009.
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EZN2968-HIF-1alpha
Santaris Pharma's collaboration partner Enzon Pharmaceuticals announcedpreliminary results of the jointly developed Hif-1alpha inhibitor targetingsolid tumors at the AACR meeting in May. Enzon expects to report the resultsof its phase I clinical trials targeting solid tumors with EZN2968 in the 2ndhalf of 2009. Further Enzon has announced its intention of initiation of aphase II trial with this compound later in 2009.
SPC2996-CLL
In accordance with Santaris Pharma's refocusing of own developmentactivities within metabolic disorders and infectious diseases, it has beendecided to divest the activities within the development of SPC2996 targetingCLL. This process is ongoing.
EZN3042-Survivin
In February 2009 Santaris Pharma's collaboration partner EnzonPharmaceuticals initiated a phase I clinical trial in solid tumors with theLNA-based drug Survivin targeting cancer.
SPC4955-ApoB inhibitor
Santaris Pharma has in rodent and primate studies shown that ApoBinhibitors are able to lower LDL cholesterol and triglycerides effectively.In Q2 2009 the Company selected a lead candidate SPC4955 for preclinicaldevelopment.
PCSK9-inhibitors
Santaris Pharma has selected lead candidates targeting PCSK9 related tohigh cholesterol. These candidates are ready for pharmacological studies.
Collaborations
Santaris Pharma has collaboration agreements with three partners,covering up to 22 novel LNA-based RNA therapeutics:
Wyeth Pharmaceuticals (December 2008)
By the end of 2008 Santaris Pharma entered into an agreement with WyethPharmaceuticals, covering 10 LNA-based drug candidates targeting variousdiseases selected by Wyeth. Under the terms of the collaboration SantarisPharma will design and generate the drug compounds and Wyeth will beresponsible for all preclinical- and clinical development as well as thecommercialization on a worldwide basis.
GlaxoSmithKline Collaboration (December 2007)
Under the terms of the collaboration with GlaxoSmithKline (GSK) on newdrugs for the treatment of viral diseases, Santaris Pharma is responsible forthe discovery and development of RNA inhibiting drug candidates through tocompletion of Phase IIa ("Clinical Proof of Concept") for four viral targets,at which point GlaxoSmithKline will have an exclusive option to license eachcompound for further development and commercialisation on a worldwide basis.Presently GSK has selected one viral disease target and Santaris Pharma hasidentified several strong drug candidates against the target.
Enzon Collaboration (August 2006)
Under the terms of the collaboration with Enzon Pharmaceuticals, SantarisPharma will design and generate a total of eight drug candidates and Enzonwill fund and manage the preclinical- and clinical development of the drugcandidates and file for regulatory approvals outside Europe. Santaris Pharmahas maintained all commercial rights for the eight drug candidates in Europe.
Enzon is expected to disclose final results from the clinical developmentof EZN/SPC2968, a HIF-1alpha inhibitor, which is currently being evaluated intwo separate Phase I/II clinical trials in patients with advanced solidtumors, in the 2nd half of 2009.
Enzon has initiated a Phase I study in various solid tumors forEZN/SPC3042, the Survivin inhibitor, in the 1st quarter of 2009.
In addition to EZN/SPC2968 and EZN/SPC3042 Enzon has now received all theremaining six novel cancer drug candidates from Santaris Pharma and Enzon hasannounced the targets for four of these compounds: Her3, beta catenin, PIK3CAand the androgen receptor.
Pipeline Summary
In H1 2009 Santaris Pharma continued the progress for both the drugdiscovery programs and the drug development pipeline. At the end of JuneSantaris Pharma had four drugs in clinical development:
In addition to the four clinical development stage compounds SantarisPharma and its partners have several other compounds in the discovery,research and preclinical stages, including the new apoB inhibitor, SPC4955which now enters preclinical development and the PCSK9 lead candidates whichare ready for pharmacological studies.
See Santaris Pharma's pipeline through this link:http://www.santaris.com/Library/documents/Santaris_Pharma_Interim_Report_1_January_to_30_June_2009.pdf
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Research
During H1 2009 Santaris Pharma and/or partners have published sixscientific articles and more have been submitted for publication:
Proc Natl Acad Sci USA
In the January 2009 issue of the journal Proc Natl Acad Sci USA SantarisPharma and its collaboration partner Claes Wahlestedt published data onLNA-based inhibition of microRNA-219 associated with schizophrenia.
Clin Cancer Research
In January 2009 Santaris Pharma and academic partners publiched anarticle titled: Uncovering growth suppressive microRNAs in lung cancer.
Cancer Research
In January 2009 Santaris Pharma published an article titled: microRNAsilencing in primates: Towards development of new therapeutics.
Clin Cancer Res
In first half of 2009 Santaris Pharma and academic partners published anarticle titled: Uncovering growth suppressive microRNAs in lung cancer
Nature Cell Biology
In first half of 2009 Santaris Pharma and academic partners published anarticle titled: A functional screen implicates microRNA-138-dependentregulation of the depalmitoylation enzyme APT1 in dendritic spinemorphogenesis.
BMC Med Genomics
In June 2009 Santaris Pharma and academic partners published an articletitled: Identification and analysis of miRNAs in human breast cancer andteratoma samples using deep sequencing.
During H1 2009 the Company made presentations at several scientificconferences:
Santaris Pharma is represented in the Advisory Board of the KeystoneSymposia.
Guidance for 2009
Santaris Pharma guidance for the year ending 31 December 2009 is a lossafter tax in the range of DKK 115 - 125 million.
Flemming Ornskov Soren Tulstrup
Chairman of the Board President and CEO
FINANCIAL REVIEW
The Financial Statements in this Interim Report are presented inaccordance with IAS 34 as adopted by the EU and additional Danish disclosurerequirements for Interim Reports of listed companies. The accounting policiesare consistent with those applied in the Annual Report for 2008. The InterimReport is un-audited and un-reviewed.
The Income Statement, the Balance Sheet, the Statement of change inEquity, the Cash Flow Statement and the Cap table are presented below.
Income Statement (1 January - 30 June 2009)
The loss after tax realised in the 2nd quarter of 2008 was 21,6m (2,9mEUR) compared to 29,8m DKK (4,0m EUR) in 2008. The accumulated loss after taxfor the first half of 2009 was 34,5m DKK (4,6m EUR) compared to 65,6m DKK(8,8m EUR) in 2008.
The Revenues for the 2nd quarter 2009 amounted to 12,6m DKK (1,7m EUR)compared to 23,1m DKK (3,1m EUR) for the same period last year.
Following the refocusing of the Company's activities, the organisationhas been significantly reduced and the total research, development andadministrative cost for the 2nd quarter of 2009 has, compared with 2ndquarter of last year, been reduced by 21,1m DKK (2,8m EUR). The year to datesaving for the period 1 January to 30 June 2009 compared to the same periodin 2008 was 29,7m DKK (4,0 EUR).
The Net Financial Income in the first half of 2009 was 9,6m DKK (1,3mEUR) compared to 6,3m DKK (0,8m EUR) in 2008.
Balance Sheet and Cash Flow
As at June 30 2009, the Company had total assets of 234,6m DKK (31,5mEUR) of which the Cash & Cash Equivalents amounted to 175,4m DKK (23,6m EUR).This cash position is, subject to the Company's receipt of certain milestonepayments related to the ongoing collaboration activities, expected to besufficient to finance the Company's operations beyond 2010.
The total Equity on June 30 2009 amounts to 187,5m DKK (25,2m EUR).
See Income Statement, Balance sheet, Statement of Change in Equity, CashFlow statement, and Cap Table through this link:http://www.santaris.com/Library/documents/Santaris_Pharma_Interim_Report_1_January_to_30_June_2009.pdf
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MANAGEMENT'S STATEMENT
The Board of Directors and Executive Management today considered andapproved the Interim Report for the period 1 January to 30 June 2009. TheInterim Report, which is unaudited and unreviewed, is presented in accordancewith international accounting standards. We consider the accounting policiesto be appropriate to the effect that the Interim Report gives a true and fairview of the Company's assets and liabilities, financial position, results ofoperations and cash flows. Furthermore, we consider the Interim Report togive a true and fair statement of the developments in the Group's activitiesand financial affairs, results of operations and the Company's financialposition as a whole as well as a description of the significant risks anduncertainties the Company faces.
Santaris Pharma forward looking statements
This written announcement contains forward-looking statements, identifiedby the use of words such as "believes," "expects," "may," "will," "should","potential," "anticipates," "plans" or "intends" and similar expressions.Such forward-looking statements involve risks, uncertainties and otherfactors that may cause actual results, events or developments to bematerially different from the future results, events or developmentsindicated in this announcement. Such factors include, but are not limited tothe timing, success and cost of clinical studies; the ability to obtainregulatory approval of products, market acceptance of and future demand forSantaris Pharma products and the impact of competitive products and pricing.These factors should be considered carefully and readers are cautioned not toplace undue reliance on such forward-looking statements. No assurance can begiven that the future results covered by the forward-looking statements willbe achieved. All information in this press release is as of the date of thispress release and Santaris Pharma does not intend to update this information.- The loss after tax realised in the 2nd quarter of 2009 was 21,6m DKK (2,9m EUR) compared to 29,8m DKK (4,0m EUR) in the 2nd quarter of 2008. - As at June 30, 2009 the capital resources totalled 175,4m DKK (23,6m EUR). - In Q2 the SPC3649 compound targeting hepatitis C finalized a single dose First/In/Man study with encouraging results and a multiple ascending dose study in healthy volunteers is scheduled to commence in Q3 2009. - Santaris Pharma's new lead candidate SPC4955 targeting apoliproteinB, the major cholesterol carrying protein in the blood, has been selected for preclinical trials. - Lead candidates targeting PCSK9, which is known to play a critical role in regulating cholesterol levels, have been selected for pharmacological studies. - The Collaboration with the Company's 3rd partner, Wyeth, was initiated during the first months of 2009 and is progressing according to the plan. (Logo: http://www.newscom.com/cgi-bin/prnh/20090420/344344 )
SOURCE Santaris Pharma
