DGAP-News: 4SC Announces Financial Results for the First Half Year 2010
(firmenpresse) - 4SC AG / Quarter Results
10.08.2010 07:30
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Planegg-Martinsried, 10 August 2010 - 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 first half
year 2010, which ended on 30 June 2010.
Highlights for the Second Quarter 2010:
- Resminostat - Phase II Hodgkin's lymphoma study SAPHIRE achieves first
Simon recruitment stage and advances into second phase of patient
enrollment
- Vidofludimus - Phase IIa inflammatory bowel disease (IBD) study
ENTRANCE - fully recruited
- Vidofludimus - preclinical data on IL-17 inhibition in IBD and lupus
published in two international peer review journals Inflammatory Bowel
Diseases and American Journal of Pathology
- Public funding from the Federal Ministry of Education and Research
(BMBF) of up to EUR1.4 million for a joint project with Nexigen GmbH to
develop innovative peptide-based cancer drugs
Dr Ulrich Dauer, CEO of 4SC, commented on the course of business, 'In the
first half of 2010, current clinical activities culminated at our company.
We were able to achieve important advancements with all our clinical
programmes, as well as our preclinical projects, as planned. By the end of
2010 we expect data from two Phase II studies and one Phase I study.
Within the next 18 months we anticipate reporting final results for a total
of six, ongoing clinical studies. These important milestones that lie
ahead of us should continue to underscore 4SC's capabilities and
attractiveness as a partner to global biotech and pharmaceutical
companies.'
Overview of results in the first half of 2010
In the first half of 2010, 4SC generated revenue of EUR0.5 million, down
from EUR1.0 million for the same period in 2009, resulting from research
collaborations. Total operating expenses for this period were EUR11.2
million, following EUR8.6 million in the first half of 2009, an increase
largely attributable to a rise in research and development costs. These
increased from EUR6.5 million to EUR9.0 million compared to the prior year
period, in line with planning, as a result of the successful expansion of
clinical development activities.
The operating loss increased as anticipated from EUR7.6 million in the
first six months of 2009 to EUR10.6 million in the first half of 2010; the
net loss for the period rose accordingly from EUR7.3 million to EUR10.6
million. The loss per share in the first half of 2010 remained virtually
flat to the prior-year period at EUR0.27 (first half 2009: EUR0.26).
Funds as at 30 June 2010 totaled EUR26.5 million (31 December 2009: EUR35.6
million).
Overview of results in the second quarter of 2010
Second-quarter results were in-line with those for the first half of the
year. Revenue declined year-on-year from EUR0.5 million to EUR0.2 million.
Operating expenses rose from EUR4.2 million to EUR5.6 million, primarily
due to the increase in research and development costs from EUR3.2 million
to EUR4.5 million. This yielded an operating loss of EUR5.3 million for the
second quarter of 2010 (second quarter of 2009: operating loss of EUR3.7
million) and also a net loss for the period of EUR5.3 million (second
quarter of 2009: net loss of EUR3.6 million). Loss per share also remained
virtually flat at EUR0.14 compared with EUR0.13 in the prior-year quarter.
Continued successful advancements in the clinical pipeline
The positive developments in the clinical programmes continued in the first
half of 2010. A total of six Phase I and Phase II studies for four clinical
product candidates progressed according to plan.
The Phase II study SAPHIRE with resminostat in Hodgkin's lymphoma (HL),
which is being conducted in two stages using the Simon design, successfully
met the clinical activity requirements for the first Simon recruitment
stage in May. This enabled the second Simon recruitment stage to be opened
so that the efficacy of resminostat could be tested in a larger patient
cohort. Simon's two-stage design aims to ensure that only if there are
objective signs of efficacy in the first patient cohort, another cohort can
be treated. For ethical reasons, this minimises the risk that patients
could be treated with an ineffective study drug as the only treatment
option.
The Phase II study SHELTER in hepatocellular carcinoma (HCC) was also
advanced in accordance to plan, the objective being to treat 50 patients in
this study.
The Company continued its preparations for the launch of another Phase I/II
study with resminostat in patients suffering from colon cancer. Planned as
a second-line treatment in combination with a standard chemotherapy regimen
(FOLFIRI) in patients with tumours that contain mutations in an important
cellular signalling molecule (known as the KRAS gene), this study is
scheduled to be commenced in Germany before the end of 2010 pending
approval by the regulatory authorities.
Patient recruitment for 4SC's autoimmune drug candidate vidofludimus was
successfully completed by mid-year for the exploratory Phase IIa study
ENTRANCE in inflammatory bowel disease (IBD). Predictive study data is
therefore expected in the second half of the year. This exploratory study
was commenced to deliver first efficacy data for vidofludimus in IBD and
consequently leverage this compound's broader commercial potential in
addition to the rheumatoid arthritis (RA) indication. In the study, 4SC is
investigating whether steroid-based treatment can be replaced or reduced
through vidofludimus and whether further inflammation can be suppressed, on
an ongoing basis, without patients suffering further side effects.
Good progress was also made with the Phase IIb study COMPONENT with
vidofludimus in RA. In parallel, comprehensive preclinical data was
published on vidofludimus in the peer-review journals Inflammatory Bowel
Diseases and American Journal of Pathology, to substantiate its broad
applicability in autoimmune diseases. On the one hand, the role of
vidofludimus as a suppressor of the cytokine Interleukin 17 (IL-17), an
inflammatory messenger, was highlighted. It was demonstrated that
vidofludimus substantially improves the symptoms of inflammatory bowel
disease and significantly inhibits the production of IL-17 both in vitro
and in vivo. On the other hand, vidofludimus was demonstrated to be as
effective as the standard therapy high dose cyclophosphamide (CYC) in
controlling systemic lupus erythematosus (SLE) without causing
myelosuppression, which is frequently seen with CYC. These results broaden
the potential use of vidofludimus as an orally administered baseline
therapy for treating autoimmune diseases such as RA and IBD - both
indications that are at the forefront of 4SC's clinical development
strategy.
Progress was also made in the two Phase I studies with the multi-kinase
inhibitor 4SC-203 and the oral Eg5 inhibitor 4SC-205. The results of the
Phase I study on volunteers are expected In the course of the current year
for the compound 4SC-203 which was developed in collaboration with
ProQinase GmbH, Freiburg, Germany. Due to its target selectivity profile,
4SC-203 will be specifically tested for its anti-tumour activity in
patients suffering from acute myeloid leukemia (AML). In this form of
leukemia, the FLT3 kinase is a particularly disease-relevant target.
In addition to the progress made in the clinical programmes, the
preclinical development of two further oncology projects, the selective
class I HDAC inhibitor 4SC-202 and the cell-cycle blocker 4SC-207, was
pursued in the second quarter of 2010. It is planned to commence Phase I
clinical development for the compound 4SC-202, which exhibits a very
different activity profile to the further developed HDAC inhibitor
resminostat, in 2010.
4SC announced in April that it had secured additional public funding. The
German Federal Ministry of Education and Research (BMBF) is providing up to
EUR1.4 million in grants for a project implemented in collaboration with
Nexigen GmbH, Bonn, Germany, under the 'KMU-Innovativ' programme. This
project will develop innovative peptide-based cancer drugs which have the
potential to expand 4SC's pipeline with new classes of drugs in the medium
term.
At the same time, 4SC is pleased to report that it received two
international awards from independent juries for its transparent and clear
communication with shareholders. The Company won a platinum award from the
League of American Communications Professionals (LACP) for its 2009 annual
report. From 4,000 international submitted reports, 4SC received first
place in the biotech category (revenue of up to US$1 billion). 4SC was also
successful in the Annual Report Competition (ARC), receiving the gold
award, which is the highest possible distinction.
Outlook
4SC currently expects to announce two significant value-generating Phase II
results in autoimmune disease in the second half of 2010. The results for
vidofludimus in the Phase IIa study in IBD are scheduled to be reported in
the second half of 2010, while the results for the same drug candidate in
the Phase IIb study in RA are expected at the end of 2010. Phase I results
for the compound 4SC-203 are also due to become available this year. In
addition, the commencement of a Phase I/II colon cancer study with
resminostat and the commencement of 4SC-202 in Phase I development will
enhance the sustainability of the Company's product pipeline in 2010.
For the first half year 2011 further important clinical results in the
oncology pipeline are expected.
4SC is well positioned financially to meet all of the above-mentioned
milestones within its current financial planning. 4SC's stated goal is
still to become a key partner for global biotech companies and the
pharmaceutical industry by developing innovative drug candidates for
autoimmune diseases and oncology.
The complete half year financial report will be available from 9am today at
www.4sc.com/investors.
Conference Call
The senior management team of 4SC will host a conference call at 3pm CET
(9am EST) today to inform about the results for the half year and all
important developments in the reporting period.
Participants can access the conference call under the following telephone
numbers:
Dial-in numbers::
0800 10 12 072 (Germany)
0800 358 0886 (UK)
+1 877 941 8633 (USA)
+49 6958 999 0805 (other countries)
Conference ID:
4342127
Approximately two hours after the live presentation, an audio replay of the
conference will be available on the 'investors' section of www.4sc.com.
For more information please contact:
4SC AG
Yvonne Alexander
Investor&Public Relations
Tel.: +49 (0) 89 70 07 63 - 66
yvonne.alexander(at)4sc.com
MC Services
Raimund Gabriel
Tel.: +49 (0) 89 21 02 28 30
raimund.gabriel(at)mc-services.eu
About 4SC
4SC AG (ISIN DE0005753818) is a drug discovery and development company
focused on autoimmune and cancer indications. Vidofludimus (4SC-101), a
small molecule, is currently in a Phase IIb study in rheumatoid arthritis
and a Phase IIa exploratory study in inflammatory bowel disease. The
company's lead oncology compound, resminostat (4SC-201), a pan histone
deacetylase (HDAC) inhibitor, is in Phase II trials in hepatocellular
carcinoma and Hodgkin'slymphoma. 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.
10.08.2010 07:30 Ad hoc announcement, Financial News and Press Release distributed by DGAP. Medienarchiv atwww.dgap-medientreff.deandwww.dgap.de---------------------------------------------------------------------------
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(at)4sc.com
Internet: www.4sc.de
ISIN: DE0005753818
WKN: 575381
Listed: Regulierter Markt in Frankfurt (Prime Standard); Freiverkehr
in München, Düsseldorf, Berlin, Stuttgart
End of News DGAP News-Service
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Datum: 10.08.2010 - 07:30 Uhr
Sprache: Deutsch
News-ID 31922
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