4SC AG (Frankfurt, Prime Standard: VSC), a drug discovery and
development company focused on autoimmune and cancer indications,
today announced its financial results in accordance with
International Financial Reporting Standards (IFRS) for the year
ended 31 December 2010.
The year 2010 was a highly successful one for 4SC. As the year
progressed, the Company made significant advances in its entire
clinical product portfolio and reported promising results from its
ongoing Phase II development programmes with resminostat in the
field of oncology and vidofludimus for the treatment of autoimmune
diseases. By the end of the year, 4SC had a robust and mature
product pipeline with no fewer than four small-molecule compounds
in six clinical studies and two more preclinical programmes.
Highlights in 2010:
- Proof-of-concept for vidofludimus in
inflammatory bowel disease - positive Phase IIa results in the
ENTRANCE study
- Completion of patient recruitment for
vidofludimus in the Phase IIb COMPONENT study in rheumatoid
arthritis
- Positive interim results for
resminostat from the Phase II SHELTER study for treating patients
with hepatocellular carcinoma and from the Phase II SAPHIRE study
for the treatment of Hodgkin's lymphoma
- Expansion of the pipeline and its
sustainability through the launch of two new Phase I programmes
with the multi-kinase inhibitor 4SC-203 as well as the oral Eg5
kinesin spindle protein inhibitor 4SC-205 in patients with solid
tumours and malignant lymphomas
- Cash balance of EUR17.6 million at 31
December 2010
Dr Ulrich Dauer, CEO of 4SC, commented on the course of
business: '2010 was a highly successful year for us. We sharpened
our profile as a leading developer of targeted small-molecule
therapies for autoimmune diseases and cancer and underpinned our
success with solid data. We hope to continue this positive momentum
in the new financial year. 2011 will be a decisive year for us: we
expect results from three Phase II studies with our two lead
compounds - resminostat in oncology and vidofludimus for the
treatment of autoimmune diseases.'
Financial results in 2010
In the 2010 financial year, 4SC generated total revenue of just
under EUR1.0 million. This figure was reduced compared with
previous year's figure of EUR1.9 million due to the concentration
of resources on the implementation of 4SC's own development
programmes.
The initiation of three more clinical studies and the progress
made in the existing clinical development programmes increased
research and development expenses, as expected, from EUR14.2
million in 2009 to EUR17.0 million in 2010. Administrative costs
rose slightly year-on-year from EUR3.4 million to EUR3.6
million.
The increase in development costs raised the net loss to EUR20.1
million in 2010 from EUR16.1 million in 2009.
As a result of the capital increase implemented at the end of
2009, the number of shares in the reporting period was 38,502,739,
up from an average of 29,752,739 in the previous year. The loss per
share fell accordingly to EUR0.52, compared with EUR0.54 in
2009.
Cash flows
At 31 December 2010, 4SC AG had funds of EUR17.6 million (2009:
EUR35.6 million). Cash and cash equivalents amounted to just under
EUR5.0 million at the reporting date. Other funds of EUR12.7
million were invested in current financial assets.
While no capital measures took place in 2010, 4SC successfully
completed a capital increase in February 2011, shortly after the
end of the reporting period. The new shares were placed exclusively
with new institutional investors from Germany, the Benelux
countries, Scandinavia and the United States. This increased the
free float from around 19.4% to approximately 26.0%. By issuing
3,452,647 new shares at EUR3.40 per share, the Company generated
gross issue proceeds of around EUR11.74 million.
Outlook
In 2011, 4SC anticipates final Phase II data from three clinical
studies and, with this, the potential proof-of-concept for
vidofludimus in rheumatoid arthritis as well as for resminostat in
the two indications of hepatocellular carcinoma and Hodgkin's
lymphoma. This will boost the value of the products and increase
the Company's enterprise value.
Mid-2011, 4SC plans to present top line data from the Phase IIb
COMPONENT study with vidofludimus in rheumatoid arthritis. Positive
results were already reported in November 2010 for the Phase IIa
study in inflammatory bowel disease.
In its oncology portfolio, 4SC expects results from two Phase II
studies for resminostat in 2011 in the indications Hodgkin's
lymphoma and hepatocellular carcinoma. Initial encouraging data
from these two studies were published at the end of 2010.
A further Phase I/II clinical trial called SHORE was commenced
in January 2011 to evaluate the same compound in colon cancer
patients with KRAS mutations.
Two more Phase I programmes strengthen the clinical oncology
pipeline in 2011. Positive Phase I data were already reported for
4SC-203 in January 2011. Results for 4SC-205 are also expected in
the course of 2011.
Under the Company's current plans, research and development
costs in 2011 and 2012 will remain at more or less the same level
as in 2010. As a result, 4SC anticipates posting a loss once again
for both years.
4SC reached important drug development milestones in 2010. In
connection with the successful capital increase implemented in
February 2011, 4SC believes it has a very strong position from
which to achieve its set development goals for the coming months as
well as to negotiate possible licensing partnerships for one or
several of its programmes.
The complete annual financial report will be available for
download at www.4sc.com/Investors from 8:00 am CET.
Telephone Conference and Webcast
4SC will host a telephone conference at 3:00 pm CET (9:00 am
EST) today. The senior management team will inform about the key
developments in financial year 2010 and will provide an update on
the development programmes.
Access to the presentation slides can be obtained at:
http://4sc290311-live.cyber-presentation.de
To participate in the telephone conference, please use the
following data:
Date: 29 March 2011Time: 3:00 pm CET (9:00 am EST)Dial-in
numbers: 0800 10 12 072 (Germany)0800-358-0886 (UK)1-877-941-6012
(USA)+49 6103 485 3001 (other countries)
Conference ID: 4421825
Approximately two hours after the live presentation, an audio
replay of the conference will be available on the 'investors'
section of www.4sc.com.
About 4SC
4SC AG (ISIN DE0005753818) discovers and develops targeted small
molecules for autoimmune and cancer indications. Vidofludimus
(4SC-101), an oral IL-17 inhibitor, is currently in Phase II
development in rheumatoid arthritis and inflammatory bowel disease
(IBD), for which positive results from a Phase IIa study were
recently reported. The company's lead oncology compound,
resminostat (4SC-201), an oral pan-histone deacetylase (HDAC)
inhibitor, is in Phase II trials in hepatocellular carcinoma,
Hodgkin's lymphoma and KRAS-mutant colorectal cancer. Two further
oncology compounds, 4SC-203 and 4SC-205, are in Phase I studies.
4SC develops drug candidates until proof-of-concept in order to
generate value creating partnerships with the pharmaceutical
industry in return for advance and milestone payments as well as
royalties.
Founded in 1997, 4SC has 94 employees and has been listed on the
Prime Standard of the Frankfurt Stock Exchange since December
2005.
For further information, please visit www.4sc.com.
Legal Note This document may contain projections or estimates
relating to plans and objectives relating to our future operations,
products, or services; future financial results; or assumptions
underlying or relating to any such statements; each of which
constitutes a forward-looking statement subject to risks and
uncertainties, many of which are beyond our control. Actual results
could differ materially, depending on a number of factors.
Language: English Company: 4SC AG Am Klopferspitz 19a 82152
Martinsried Deutschland Phone: +49 (0)89 7007 63-0 Fax: +49 (0)89
7007 63-29 E-mail:
public@4sc.com
Internet:
www.4sc.de
ISIN: DE0005753818 WKN: 575381 Listed: Regulierter Markt in
Frankfurt (Prime Standard); Freiverkehr in Berlin, Düsseldorf,
München, Stuttgart
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