DGAP-News: 4SC Announces Financial Results for the First Quarter 2011
(firmenpresse) - DGAP-News: 4SC AG / Key word(s): Quarter Results
4SC Announces Financial Results for the First Quarter 2011
10.05.2011 / 07:30
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Planegg-Martinsried, 10 May 2011 - 4SC (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 quarter ended 31
March 2011.
Highlights of the first quarter 2011:
- 4SC-203 - Publication of the results from the Phase I clinical study
with the multi-kinase inhibitor
- Resminostat - Commencement of the Phase I/II SHORE study in the third
target indication of colorectal cancer in patients with K-ras-mutated
tumours
- Vidofludimus - Presentation of the final results from the Phase IIa
ENTRANCE study on the treatment of patients suffering from inflammatory
bowel disease
- Capital increase - Successful placement of 3,452,647 new shares with
new European and US institutional investors at a price of EUR3.40 per
share. The gross issue proceeds amounted to approximately EUR11.74
million.
Dr Ulrich Dauer, CEO of 4SC, commented: 'We have made a very successful
start to 2011 so far. Investor confidence and our first development
partnership with Yakult Honsha have validated both our business strategy
and our development pipeline. With the successful conclusion of our capital
increase and our pharma partnership, we now have a stronger starting point
from which to negotiate further potential licensing deals for one or more
of our programmes. We are looking confidently into the future, especially
as regards the forthcoming results from the Phase IIb COMPONENT study for
vidofludimus in treating rheumatoid arthritis, as well as the two Phase II
resminostat studies in the indications of hepatocellular carcinoma and
Hodgkin's lymphoma.'
Overview of the financial results in the first quarter of 2011
No revenue was generated in the reporting period. As a result of the
systematic scaling back of research collaborations, 4SC continued to focus
on internal development programmes.
The operating loss posted for the first three months of 2011 amounted to
EUR4,787 thousand, down from EUR5,274 thousand in the first quarter of
2010. The improvement resulted primarily from a decrease in research and
development expenses and higher income from research grants. The loss for
the period declined accordingly by 11%, from EUR5,267 thousand in QI / 2010
to EUR4,697 thousand. On account of the lower loss for the period and as a
consequence of the capital increase in February 2011 and the related
increase in the average number of shares, both the basic and the diluted
loss per share decreased by EUR0.02 to EUR-0.12 compared with the first
three months of 2010 (EUR-0.14).
Cash and cash equivalents amounted to EUR5,521 thousand at the end of the
reporting period. Taking into account all liquid funds and the
available-for-sale securities, 4SC hat funds totalling EUR24,592 thousand
as at 31 March 2011, compared with EUR17,607 thousand at the close of 2010.
Results from the clinical pipeline
4SC enjoyed a very successful start to the 2011 financial year, as the
Company systematically pursued its strategy of establishing itself as the
leading developer of targeted, small-molecule therapies in the areas of
autoimmune diseases and cancer.
In the first quarter of 2011, 4SC not only announced the results from a
Phase I study with the 4SC-203 compound from its oncology portfolio but
also commenced a further clinical Phase I/II study (SHORE study) with its
lead compound resminostat for the treatment of patients with K-ras-mutated
colorectal cancer (CRC). With the SHORE study, the Company has successfully
implemented its three-pillar strategy for resminostat.
Shortly after the end of the reporting period, 4SC was also able to
announce its first licensing deal for this compound on 14 April 2011. 4SC
has granted the Japanese pharma company Yakult Honsha an exclusive license
for the further development and marketing of resminostat in Japan in the
indications of hepatocellular carcinoma (HCC) and colorectal cancer (CRC).
During the reporting period, 4SC also published final data from the Phase
IIa ENTRANCE study of vidofludimus in patients with inflammatory bowel
disease (IBD), which once again confirmed the top-line result announced at
the end of 2010. The primary endpoint was met with a response rate of
88.5%.
Successful capital increase
In February 2011, 4SC successfully completed a capital increase. The
Company placed 3,452,647 new shares with new institutional investors at a
price of EUR3.40 per share, thus generating gross issue proceeds of around
EUR11.74 million. The number of no-par value bearer shares rose accordingly
from 38,502,739 to 41,955,386. Given its current capital resources, the
Company believes it is well positioned to achieve its development goals in
the coming months and to conclude further licensing deals for one or more
of its programmes.
Outlook
For 4SC, the 2011 financial year is of particular importance. The Company
is expecting final Phase II data from three clinical studies and, with
this, the potential proof-of-concept for vidofludimus in rheumatoid
arthritis (RA) and for resminostat in the two indications of HCC and HL.
Alongside data evaluation, 4SC is continuing efforts to intensify
discussions with potential licensing partners for all current clinical
programmes.
In the second quarter of 2011, 4SC plans to present top-line data from the
Phase IIb COMPONENT study with vidofludimus in RA. Positive results for the
Phase IIa study in IBD were already reported in November 2010 and towards
the end of February 2011. Should the data from the COMPONENT study provide
further confirmation of the highly promising potential of vidofludimus in
the treatment of autoimmune diseases, this will once again considerably
increase the value of the product as regards potential licensing deals.
In its oncology portfolio, 4SC in the 2011 financial year expects final
results from two Phase II studies for resminostat in the indications HCC
and HL. Encouraging data from these two studies have already been
published. Here, too, further confirmation of the current positive dataset
would lead to a considerable increase in product value for both 4SC and for
potential licensing partners. The license agreement signed with Yakult
Honsha concerning the development and commercialisation of the compound in
Japan already recognises the potential of resminostat at an early stage.
Two more Phase I programmes will strengthen the clinical oncology pipeline
in 2011. Positive Phase I data were reported for 4SC-203 in January 2011.
Phase I results for 4SC-205 are also expected during the course of 2011.
A further Phase I study with 4SC-202, the second HDAC inhibitor owned by
4SC, was commenced in April 2011, shortly after the end of the reporting
period. Initial data from this study are likely to be published in 2012.
4SC has a solid financial basis. Accordingly, and not least on account of
the successful execution of its capital increase in February 2011, the
Company believes it has a strong position from which to achieve its set
development goals for the coming months as well as to negotiate additional
possible licensing partnerships for one or several of its programmes. This
strong position was enhanced further with the recent signing of the
licensing agreement with Yakult Honsha.
Conference call
The senior management team of 4SC will host a conference call at 3pm CET
(9am EST) today to present the results for the first quarter and provide
information on all important developments in the reporting period.
Participants can dial in to the conference call using the following
telephone numbers:
Dial-in numbers:
0800 10 12 072 (Germany)
0800 358 0886 (UK)
1-877-941-1469 (USA)
+49 6958 999 0804 (other countries)
Conference ID: 4437460
Approximately two hours after the live presentation, an audio replay of the
conference will be available on the 'investors' section of www.4sc.com.
The complete quarterly report will be available from 9am today at
www.4sc.com/investors.
About 4SC
4SC AG (ISIN DE0005753818) discovers and develops targeted small molecules
for autoimmune and cancer indications. Vidofludimus (4SC-101), an IL-17 and
DHODH 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. 4SC has further oncology
products in Phase I development, including 4SC-202, 4SC-203 and 4SC-205.
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.
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
End of Corporate News
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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 Berlin, Düsseldorf, München, Stuttgart
End of News DGAP News-Service
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123586 10.05.2011
Datum: 10.05.2011 - 07:30 Uhr
Sprache: Deutsch
News-ID 34002
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