DGAP-News: 4SC announces financial results for the third quarter and first nine months of 2011
(firmenpresse) - DGAP-News: 4SC AG / Key word(s): Quarter Results
4SC announces financial results for the third quarter and first nine
months of 2011
08.11.2011 / 07:30
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4SC announces financial results for the third quarter and first nine months
of 2011
Planegg-Martinsried, Germany, 8 November 2011 - 4SC AG (Frankfurt, Prime
Standard: VSC), a discovery and development company of targeted small
molecule drugs for autoimmune diseases and cancer, today announced its
financial results in accordance with International Financial Reporting
Standards (IFRS) for the third quarter and first nine months of 2011.
Key results in the third quarter of 2011:
- Resminostat - US Food and Drug Administration (FDA) grants orphan drug
status to the lead oncology compound in the indications of
hepatocellular carcinoma (HCC) and Hodgkin's lymphoma (HL), a type of
lymph node cancer
- Resminostat - European Medicines Agency (EMA) recommends resminostat
for designation as an orphan medicinal product in the EU in the
indication of HCC
- Resminostat - Announcement of positive top-line results from the Phase
II SAPHIRE study in the HL indication
Dr Ulrich Dauer, CEO of 4SC commented: 'In the third quarter of 2011, we
focused in particular on the advancement of resminostat, our lead oncology
compound. The results of the Phase II SAPHIRE study in patients with
Hodgkin's lymphoma that we announced in September were especially
encouraging in this context. The data showed clear anti-tumour activity and
once again demonstrated the compound's good safety and tolerability
profile. We are now looking forward with great anticipation to the results
from our Phase II SHELTER study in HCC patients so that we can promptly
discuss the next development steps in these indications with the regulatory
authorities.'
Dr Ulrich Dauer continued: 'Given the tense situation on the financial
markets at present, we decided to concentrate our activities over the next
months on developing our most advanced compounds - resminostat and
vidofludimus - as well as the anti-cancer compound 4SC-202, because we
believe they have the highest potential to increase 4SC's value within the
next twelve months. The cost savings this will generate are expected to
provide funding for our Company until the beginning of 2013, longer than
previously communicated.'
After the end of the reporting period - in October 2011 - the European
Medicines Agency (EMA) recommended resminostat as an orphan medicinal
product in the EU for the treatment of HL as well. Furthermore, 4SC
announced the final results of its Phase IIb COMPONENT study with the
immune modulator vidofludimus in patients with rheumatoid arthritis (RA) at
the ACR conference in Chicago, USA, on 6 November 2011. In this study, the
compound showed a substantial reduction of objective inflammatory
parameters in RA patients and, combined with its excellent safety profile
that was demonstrated once again, confirmed its high potential for treating
various autoimmune diseases including inflammatory bowel disease (IBD).
Overview of the financial results in the third quarter and first nine
months of 2011
4SC posted revenue of EUR223 thousand in the reporting quarter. It was
generated from deferred income recognised as a result of the up-front
payment received from Yakult Honsha in connection withthe licence
agreement for resminostat in Japan in April 2011. 4SC posted revenue of
EUR443 thousand in the first nine months of the year. Operating expenses in
the third quarter were EUR5,069 thousand, up 3 % from EUR4,922 thousand in
the same period the previous year. Operating expenses for the first nine
months, however, decreased by 8 % from EUR16,085 thousand in the first nine
months of 2010 to EUR14,833 thousand in the 2011 reporting period.
Development costs caused by the ongoing clinical studies made up a large
part of operating expenses. On a year-for-year basis, research and
development costs fell by 4 % in the third quarter to EUR3,792 thousand
(previous year: EUR3,963 thousand) and by 13 % in the first nine months to
EUR11,331 thousand (previous year: EUR12,989 thousand).
The operating loss posted for the first nine months of 2011 decreased to
EUR14,385 thousand, down 6 % from EUR15,303 thousand in the first nine
months of 2010. The net loss for the period in the first nine months also
declined by some 6 %, from EUR15,165 thousand in 2010 to EUR14,681 thousand
in the reporting period. As a result of the capital increase in February
2011, which increased the number of shares, the loss per share fell in the
reporting period. The Company recorded a loss per share of EUR0.11 in the
third quarter (previous year: EUR0.12). The loss per share for the first
nine months was impacted by the lower loss for the period, dropping from
EUR0.39 in the previous year to EUR0.35 in 2011.
On 30 September 2011, the 4SC had cash and available-for-sale securities
totalling EUR20,220 thousand, compared with EUR17,607 thousand at the end
of 2010.
Results from the clinical pipeline
Attention in the third quarter of 2011 was focused primarily on 4SC's lead
oncology compound resminostat, an orally administered pan-HDAC inhibitor.
The US Food and Drug Administration (FDA) granted orphan drug status to
resminostat in the indications of hepatocellular carcinoma (HCC) and
Hodgkin's lymphoma (HL). The European Medicines Agency (EMA) also
recommended resminostat as an orphan medicinal product in the EU - both for
the treatment of HCC and, shortly after the reporting period, HL.
Furthermore, in early September 2011 4SC announced encouraging top-line
results from its Phase-II SAPHIRE study with resminostat in the HL
indication. The primary study endpoint was met and the drug's previously
observed positive safety and tolerability profile was confirmed.
Outlook
Following the announcement of positive top-line results from the Phase II
SAPHIRE study with resminostat in the HL indication, 4SC is now awaiting
results from the Phase II SHELTER study with resminostat in patients with
hepatocellular carcinoma (HCC), the most common form of liver cancer, in
the next few months. Given the current, highly advanced status of patient
recruitment, 4SC expects to be able to announce the top-line results early
next year. Based on the final data from these two studies, the Company will
then discuss its plans with medicines agencies for a 'pivotal' programme,
i.e. a development programme for resminostat aimed at achieving regulatory
approval. Besides HL and HCC, resminostat will be further investigated in a
third indication: colon cancer. Initial results from the ongoing Phase I/II
SHORE study are expected in 2012.
Progress is also being made in the Company's other clinical development
programmes in the field of oncology. Patient recruitment for the Phase I
AEGIS study of the compound 4SC-205 in patients with solid tumours or
lymphomas is expected to be completed as planned in 2011. After the data
has been analysed, the results will be available for publication early next
year. In 2012, the Company also expects to deliver initial results from the
Phase I TOPAS trial with the compound 4SC-202 in patients with advanced
haematological cancers.
In the area of autoimmune diseases, a Phase IIb study with vidofludimus in
patients with inflammatory bowel disease (IBD) is currently being prepared.
In parallel, 4SC is holding talks with potential partners and medicines
agencies for the implementation of this trial. Strengthened by the
encouraging results from the completed Phase IIa ENTRANCE study with
vidofludimus in IBD as well as the recently published final efficacy data
of the compound with regard to objective inflammation parameters in
patients with rheumatoid arthritis (RA) from the Phase IIb COMPONENT study,
the Company is optimistic about achieving a positive outcome in these
talks.
4SC had funds of EUR20,220 thousand at the end of the third quarter. Given
the very tense situation on the capital markets at present, the Company
decided, starting from the beginning of the fourth quarter, to concentrate
on selectively continuing the clinical programmes which it believes have
the highest potential to increase the Company's value within the next
twelve months. For this reason, the Company will focus on its most advanced
drugs - resminostat and vidofludimus - as well as on the anti-cancer
compound 4SC-202. The cost savings this will generate are expected to
provide funding for the Company until the beginning of 2013, longer than
previously communicated.
The complete nine-month financial report will be available from 8am CET
today on the Company's website at www.4sc.com/investors.
Conference call
The Management Board of 4SC will host a conference call at 3pm CET (9am
EST) today to present the financial results and provide information on all
important developments in the reporting period.
Participants can dial in to the conference call using the following
telephone numbers:
Date: 8 November 2011
Time: 3pm CET (9am EST)
Dial-in numbers:
0800 10 12 072 (Germany)
0800 358 0886 (UK)
+ 1 877 941 1469 (USA)
+49 6958 999 0806 (other countries)
Conference ID: 4482477
Approximately two hours after the live conference, an audio replay of the
conference call will be available on the 'investors' section of
www.4sc.com.
About 4SC
4SC (ISIN DE0005753818) discovers and develops targeted small-molecule
drugs for the treatment of diseases with a high unmet medical need in
various autoimmune and cancer indications. These drugs are intended to
provide patients with innovative treatment options that are more tolerable
and efficacious than existing therapies, and provide a better quality of
life. The company's balanced pipeline comprises promising products that are
in various stages of clinical development. 4SC's aim is to generate future
growth and enhance its enterprise value by entering into partnerships with
leading pharmaceutical companies. Founded in 1997, 4SC currently has 94
employees and has been listed on the Prime Standard of the Frankfurt Stock
Exchange since December 2005.
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 visit www.4sc.com or contact:
4SC AG
Jochen Orlowski, Investor Relations&Public Relations
jochen.orlowski(at)4sc.com
Tel.: +49 (0) 89 70 07 63 0
Bettina v. Klitzing-Stückle, Corporate Communications
bettina.von.klitzing(at)4sc.com
Tel.: +49 (0) 89 70 07 63 0
MC Services (Europe)
Raimund Gabriel
raimund.gabriel(at)mc-services.eu
Tel.: +49 (0) 89 21 02 28 30
Mareike Mohr
mareike.mohr(at)mc-services.eu
Tel.: +49 (0) 89 21 02 28 40
The Trout Group (USA)
Chad Rubin
Crubin(at)troutgroup.com
Tel.: +1 646 378 2947
End of Corporate News
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08.11.2011 Dissemination of a Corporate News, transmitted by DGAP - a
company of EquityStory AG.
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Language: English
Company: 4SC AG
Am Klopferspitz 19a
82152 Martinsried
Germany
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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