Santaris Pharma – Interim Report for the Period 1 January to 30 June 2009
HORSHOLM,
Santaris Pharma has approved the Interim Report for the period 1 January to
- 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
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
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 (
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 (
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 (
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
has maintained all commercial rights for the eight drug candidates in
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
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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
Pharma and its collaboration partner Claes Wahlestedt published data on
LNA-based inhibition of microRNA-219 associated with schizophrenia.
Clin Cancer Research
In
article titled: Uncovering growth suppressive microRNAs in lung cancer.
Cancer Research
In
silencing in primates: Towards development of new therapeutics.
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
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
after tax in the range of
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 –
The loss after tax realised in the 2nd quarter of 2008 was 21,6m (2,
EUR
for the first half of 2009 was 34,
(8,
The Revenues for the 2nd quarter 2009 amounted to 12,
compared to 23,
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,
saving for the period 1 January to
in 2008 was 29,
The Net Financial Income in the first half of 2009 was 9,
EUR
Balance Sheet and Cash Flow
As at
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
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
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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
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