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Santaris Pharma - Interim Report for the Period 1 January to 30 June 2009

Posted on: Tuesday, 14 July 2009, 08:16 CDT

HORSHOLM, Denmark, July 14 /PRNewswire/ -- The Board of Directors of Santaris Pharma has approved the Interim Report for the period 1 January to 30 June 2009.

- 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 )

During the first half of 2009 Santaris Pharma continued to make satisfactory progress in its research and development programs within miRNA, metabolic disorders and infectious diseases. Key milestones achieved and other events during the quarter are summarized below.

Development

SPC3649-HCV

SPC3649 is a potent and specific inhibitor of microRNA-122 known to be involved in cholesterol metabolism and in hepatitis virus replication in the liver. In April 2009, Santaris Pharma completed a Phase I First-in-Man single dose study of SPC3649 with 60 healthy volunteers and the Company expects to publicize 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 in healthy volunteers has been submitted and the trial is scheduled to be commenced later in 2009. Further a three months tox study will be initiated during the 2nd half of 2009.

EZN2968-HIF-1alpha

Santaris Pharma's collaboration partner Enzon Pharmaceuticals announced preliminary results of the jointly developed Hif-1alpha inhibitor targeting solid tumors at the AACR meeting in May. Enzon expects to report the results of its phase I clinical trials targeting solid tumors with EZN2968 in the 2nd half of 2009. Further Enzon has announced its intention of initiation of a phase II trial with this compound later in 2009.

SPC2996-CLL

In accordance with Santaris Pharma's refocusing of own development activities within metabolic disorders and infectious diseases, it has been decided to divest the activities within the development of SPC2996 targeting CLL. This process is ongoing.

EZN3042-Survivin

In February 2009 Santaris Pharma's collaboration partner Enzon Pharmaceuticals initiated a phase I clinical trial in solid tumors with the LNA-based drug Survivin targeting cancer.

SPC4955-ApoB inhibitor

Santaris Pharma has in rodent and primate studies shown that ApoB inhibitors are able to lower LDL cholesterol and triglycerides effectively. In Q2 2009 the Company selected a lead candidate SPC4955 for preclinical development.

PCSK9-inhibitors

Santaris Pharma has selected lead candidates targeting PCSK9 related to high 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 Wyeth Pharmaceuticals, covering 10 LNA-based drug candidates targeting various diseases selected by Wyeth. Under the terms of the collaboration Santaris Pharma will design and generate the drug compounds and Wyeth will be responsible for all preclinical- and clinical development as well as the commercialization on a worldwide basis.

GlaxoSmithKline Collaboration (December 2007)

Under the terms of the collaboration with GlaxoSmithKline (GSK) on new drugs for the treatment of viral diseases, Santaris Pharma is responsible for the discovery and development of RNA inhibiting drug candidates through to completion of Phase IIa ("Clinical Proof of Concept") for four viral targets, at which point GlaxoSmithKline will have an exclusive option to license each compound for further development and commercialisation on a worldwide basis. Presently GSK has selected one viral disease target and Santaris Pharma has identified several strong drug candidates against the target.

Enzon Collaboration (August 2006)

Under the terms of the collaboration with Enzon Pharmaceuticals, Santaris Pharma will design and generate a total of eight drug candidates and Enzon will fund and manage the preclinical- and clinical development of the drug candidates and file for regulatory approvals outside Europe. Santaris Pharma has maintained all commercial rights for the eight drug candidates in Europe.

Enzon is expected to disclose final results from the clinical development of EZN/SPC2968, a HIF-1alpha inhibitor, which is currently being evaluated in two separate Phase I/II clinical trials in patients with advanced solid tumors, in the 2nd half of 2009.

Enzon has initiated a Phase I study in various solid tumors for EZN/SPC3042, the Survivin inhibitor, in the 1st quarter of 2009.

In addition to EZN/SPC2968 and EZN/SPC3042 Enzon has now received all the remaining six novel cancer drug candidates from Santaris Pharma and Enzon has announced the targets for four of these compounds: Her3, beta catenin, PIK3CA and the androgen receptor.

Pipeline Summary

In H1 2009 Santaris Pharma continued the progress for both the drug discovery programs and the drug development pipeline. At the end of June Santaris Pharma had four drugs in clinical development:

- SPC3649, an LNA-antimiR(R) against microRNA-122, being developed for the treatment of HCV infections - EZN/SPC2968, a HIF-1alpha inhibitor, being developed for the treatment of various solid tumors - SPC2996, a Bcl-2 inhibitor, being developed for the treatment of cancer. Santaris Pharma has initiated the process of divesting this candidate - EZN3042, an LNA-based Survivin inhibitor, being developed for the treatment of various solid tumors

In addition to the four clinical development stage compounds Santaris Pharma and its partners have several other compounds in the discovery, research and preclinical stages, including the new apoB inhibitor, SPC4955 which now enters preclinical development and the PCSK9 lead candidates which are ready for pharmacological studies.

See Santaris Pharma's pipeline through this link: http://www.santaris.com/Library/documents/Santaris_Pharma_Interim_Report_1_Ja nuary_to_30_June_2009.pdf

(Due to the length of this URL, it may be necessary to copy and paste this hyperlink into your Internet browser's URL address field. Remove the space if one exists.)

Research

During H1 2009 Santaris Pharma and/or partners have published six scientific 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 Santaris Pharma and its collaboration partner Claes Wahlestedt published data on LNA-based inhibition of microRNA-219 associated with schizophrenia.

Clin Cancer Research

In January 2009 Santaris Pharma and academic partners publiched an article titled: Uncovering growth suppressive microRNAs in lung cancer.

Cancer Research

In January 2009 Santaris Pharma published an article titled: microRNA silencing in primates: Towards development of new therapeutics.

Clin Cancer Res

In first half of 2009 Santaris Pharma and academic partners published an article titled: Uncovering growth suppressive microRNAs in lung cancer

Nature Cell Biology

In first half of 2009 Santaris Pharma and academic partners published an article titled: A functional screen implicates microRNA-138-dependent regulation of the depalmitoylation enzyme APT1 in dendritic spine morphogenesis.

BMC Med Genomics

In June 2009 Santaris Pharma and academic partners published an article titled: Identification and analysis of miRNAs in human breast cancer and teratoma samples using deep sequencing.

During H1 2009 the Company made presentations at several scientific conferences:

- Small RNAs and cancer/Paris/France - Keystone, Scientific Advisory Board Meeting/Colorado/USA - Executing the promise of RNAi/Cambrigde/MA/USA - Cell & Gene Therapy/Washington/USA - St. Kitts microRNA symposium/(organizer)/St. Kitts/ Caribbean - Molecular Imaging and Drug Development/London/UK - BioEurope Spring/Milan/Italy - microRNAs in human disease/Boston/USA - Girindus Leadership in Oligonucleotides Symposium/Ohio/USA - Innov. Biotechn. Seoul, South Korea - microRNA in Denmark, BRIC, Cph. University, Denmark - European Association for the Study of the Liver, Copenhagen - AACR, Annual meeting. - 15th Annual Scandinavian Atherosclerosis Conference - Meeting Medicon Valley arranged by Medicon Valley Alliance, Cph. - DxRx Summit, Boston, USA - Danish Biotech Annual Meeting - Tides, Las Vegas, USA - BIO, Vancouver, USA - microRNA Symposium 2009, Vienna. - DDD Meeting Japan - SMI 4th conference on RNAi, miRNA and siRNA - XV International Symposium on Atherosclerosis - 4th Nucleic Acid Chemical Biology (NACB) Symposium, Odense

Santaris Pharma is represented in the Advisory Board of the Keystone Symposia.

Guidance for 2009

Santaris Pharma guidance for the year ending 31 December 2009 is a loss after 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 in accordance with IAS 34 as adopted by the EU and additional Danish disclosure requirements for Interim Reports of listed companies. The accounting policies are consistent with those applied in the Annual Report for 2008. The Interim Report is un-audited and un-reviewed.

The Income Statement, the Balance Sheet, the Statement of change in Equity, 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 (2,9m EUR) compared to 29,8m DKK (4,0m EUR) in 2008. The accumulated loss after tax for 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 organisation has been significantly reduced and the total research, development and administrative cost for the 2nd quarter of 2009 has, compared with 2nd quarter of last year, been reduced by 21,1m DKK (2,8m EUR). The year to date saving for the period 1 January to 30 June 2009 compared to the same period in 2008 was 29,7m DKK (4,0 EUR).

The Net Financial Income in the first half of 2009 was 9,6m DKK (1,3m EUR) 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 (31,5m EUR) 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 milestone payments related to the ongoing collaboration activities, expected to be sufficient 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, Cash Flow statement, and Cap Table through this link: http://www.santaris.com/Library/documents/Santaris_Pharma_Interim_Report_1_Ja nuary_to_30_June_2009.pdf

(Due to the length of this URL, it may be necessary to copy and paste this hyperlink into your Internet browser's URL address field. Remove the space if one exists.)

MANAGEMENT'S STATEMENT

The Board of Directors and Executive Management today considered and approved the Interim Report for the period 1 January to 30 June 2009. The Interim Report, which is unaudited and unreviewed, is presented in accordance with international accounting standards. We consider the accounting policies to be appropriate to the effect that the Interim Report gives a true and fair view of the Company's assets and liabilities, financial position, results of operations and cash flows. Furthermore, we consider the Interim Report to give a true and fair statement of the developments in the Group's activities and financial affairs, results of operations and the Company's financial position as a whole as well as a description of the significant risks and uncertainties the Company faces.

Board of Executives Soren Tulstrup Henrik Stage President & CEO Vice President & CFO Board of Directors Flemming Walter Claus Soren Carlsen Ornskov Wenninger Braestrup Chairman Vice Chairman Director Director Edwin de Graaf Anders Hinsby Martien van Holger Osch Reithinger Director Director Director Director

Santaris Pharma forward looking statements

This written announcement contains forward-looking statements, identified by 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 other factors that may cause actual results, events or developments to be materially different from the future results, events or developments indicated in this announcement. Such factors include, but are not limited to the timing, success and cost of clinical studies; the ability to obtain regulatory approval of products, market acceptance of and future demand for Santaris Pharma products and the impact of competitive products and pricing. These factors should be considered carefully and readers are cautioned not to place undue reliance on such forward-looking statements. No assurance can be given that the future results covered by the forward-looking statements will be achieved. All information in this press release is as of the date of this press release and Santaris Pharma does not intend to update this information.

For further information please contact: Henrik Stage, Chief Financial Officer Direct phone +45-4517-9888 Cell +45-4026-0900 E-mail: hs@santaris.com Randi Krogsgaard, Director, Corporate Communications Direct phone +45-4517-9879 Cell +45-2048-8384 E-mail: rmk@santaris.com

SOURCE Santaris Pharma

Source: PR Newswire

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