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4SC AG. (11/8/11). "Press Release: 4SC Announces Financial Results for the Third Quarter and First Nine Months of 2011". Planegg-Martinsried.

Organisations Organisation 4SC AG (FSE: VSC)
  Group 4SC (Group)
  Organisation 2 FDA (US Food and Drug Administration)
  Group United States (govt)
Products Product resminostat (4SC-201)
  Product 2 vidofludimus (4SC-101)
Person Person Dauer, Ulrich (Probiodrug 201805– CEO before Omeicos + Activaero + 4SC + Tripos)

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 with the 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.


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

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

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 or contact:

Jochen Orlowski, Investor Relations & Public Relations
Tel.: +49 (0) 89 70 07 63 0

Bettina v. Klitzing-Stückle, Corporate Communications
Tel.: +49 (0) 89 70 07 63 0

MC Services (Europe)
Raimund Gabriel
Tel.: +49 (0) 89 21 02 28 30

Mareike Mohr
Tel.: +49 (0) 89 21 02 28 40

The Trout Group (USA)
Chad Rubin
Tel.: +1 646 378 2947

Record changed: 2017-04-02


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