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4SC AG. (8/9/11). "Press Release: 4SC Announces Financial Results for the Second Quarter and First Half of 2011". Planegg-Martinsried.

Organisations Organisation 4SC AG (FSE: VSC)
  Group 4SC (Group)
  Organisation 2 Yakult Honsha Co., Ltd.
  Group Yakult Honsha (Group)
Products Product resminostat (4SC-201)
  Product 2 vidofludimus (4SC-101)
Persons Person Dauer, Ulrich (Probiodrug 201805– CEO before Omeicos + Activaero + 4SC + Tripos)
  Person 2 von Klitzing, Bettina (4SC 200901 Manager Public Realtions & Investor Relations)

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 second quarter and first half-year ended 30 June 2011.

Results in the second quarter of 2011:

- Resminostat - Conclusion of an exclusive licence agreement with Yakult Honsha concerning the development and commercialisation of resminostat in Japan

- Vidofludimus - Announcement of top-line results from the Phase IIb study in rheumatoid arthritis

- 4SC-202 - Commencement of a Phase I clinical study with the second HDAC inhibitor in patients with haematological and solid tumours

Dr Ulrich Dauer, CEO of 4SC commented: 'We were able to report on the progress of several programmes in our clinical product pipeline this year. In particular, we made great efforts in pushing ahead the development of our lead oncology compound, resminostat, as part of the consistent implementation of our three-pillar strategy. A major highlight in the second quarter was the licence agreement with Yakult Honsha in April for the development and commercialisation of resminostat in Japan. Other highlights included the recent granting of orphan drug status in the USA and recommendation for orphan medicinal product status in the EU for resminostat in hepatocellular carcinoma.'

Dr Ulrich Dauer continued: 'Although we suffered a setback with vidofludimus in the rheumatoid arthritis indication in June, we are very confident about the further development of this financial year considering our balanced and robust pipeline. We hope to be able to present further positive milestones from our clinical pipeline soon.'

Overview of the financial results in the second quarter and first half of 2011

4SC posted revenue of EUR0.22 million in the reporting quarter. It was generated from research cooperation agreements (EUR0.03 million) and the deferred income (EUR0.19 million) recognised as a result of the up-front payment received from Yakult Honsha in connection with the licence agreement for resminostat in Japan. The operating expenses fell by 11% to EUR4.98 million in the second quarter of 2011 compared to the same period in 2010 to EUR5.6 million - a decrease which mainly shows the reduction of research and development costs EUR3.86 million (previous year: EUR4.53 million).

The operating loss posted for the first six months of 2011 amounted to EUR9.54 million, down 10% from EUR10.62 million in the first half of 2010. The net loss for the period in the first half-year declined by 6%, from EUR10.57 million in 2010 to EUR9.93 million in the reporting period. On account of the lower loss for the period and as a consequence of the capital increase in February 2011, both the basic and the diluted loss per share decreased year-on-year by EUR0.02 to EUR0.12 in the reporting quarter and by EUR0.03 to EUR0.24 in the first six months of 2011.

Cash and cash equivalents amounted to EUR5.0 million at the end of the reporting period. Taking into account all liquid funds and the available-for-sale securities, 4SC had funds totalling EUR24.5 million as of 30 June 2011, compared with EUR17.61 million at the close of 2010.

Results from the clinical pipeline

In the second quarter, attention was mainly focused on the announcement of the results of the Phase IIb COMPONENT study (primary endpoint of the study missed) with vidofludimus for the treatment of patients with rheumatoid arthritis (RA). Also during the second quarter, very encouraging reports emerged from the Company's oncology pipeline, including the conclusion of a licence agreement with Yakult Honsha for the further development and commercialisation of resminostat in Japan, the further expansion of the clinical pipeline through the start of the Phase I TOPAS study with the second histone deacetylase (HDAC) inhibitor, 4SC-202, and the publication of new positive interim data from the ongoing Phase II SHELTER study with resminostat in hepatocellular carcinoma (HCC).

Shortly after the end of the second quarter, 4SC reported on further positive results, which are encouraging for the second half of the year. Recently the US Food and Drug Administration (FDA) granted resminostat orphan drug status in hepatocellular carcinoma (HCC), Not long afterwards, the European Medicines Agency (EMA) issued a recommendation for resminostat in the EU as an orphan medicinal product in the same indication.


4SC expects to report further results from Phase II clinical trials with the oncology compound resminostat in Hodgkin's lymphoma and hepatocellular carcinoma before the end of the year.
As these are open-label trials, 4SC has already reported positive interim data at scientific conferences over the course of the study. These interim data have been very encouraging with regards to the final outcome of these studies.

With regard to vidofludimus, 4SC believes the positive data from the ENTRANCE study in inflammatory bowel disease (IBD) patients presented in November 2010 and, especially, the positive safety data from the COMPONENT study that is now available will strengthen its ongoing development of vidofludimus in IBD. For this reason, the Company has already initiated talks with government agencies in Europe and the United States (FDA) to define the design of the next clinical study in IBD. The Company will continue to meet with representatives from international biotech and pharma companies with the aim of forging development partnerships for vidofludimus.

In order to gauge the potential of vidofludimus in rheumatoid arthritis (RA) 4SC is undertaking further data analysis, which has yet to be completed. Based on the results of this detailed analysis, further potential development of the substance in RA will be evaluated together with potential licensing partners. The continuation of the development of vidofludimus in RA by 4SC itself beyond the COMPONENT study has not been and is not envisaged in this indication without a partner.

Due to the capital increase in February 2011 and the up-front payment received from the partnership with Yakult Honsha, 4SC has an adequate financial base of EUR24.5 million to reach the future milestones mentioned above and have sufficient leverage for negotiations with potential partners. In accordance with current planning and based on an average cash burn rate of EUR1.3 million per month in 2011, the Company's cash reserves will last beyond the end of Q3 2012. By then, management still expects to generate additional cash inflows and revenue through cooperation agreements and partnerships. Full expenses for 2011 will probably be in the same range as in 2010.

The complete half-year financial report will be available from 8am CET today on the Company's website at

Conference call

The senior management team 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.

Access to the presentation slides can be obtained at:

Participants can dial in to the conference call using the following telephone numbers:
Date: 9 August 2011
Time: 3pm CET (9am EST)
Dial-in numbers:
0800 10 12 072 (Germany)
0800 358 0886 (UK)
1-877-941-1469 (USA)
+49 6103 485 3001 (other countries)
Conference ID: 4460983

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 further information, please visit or contact:

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

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

Record changed: 2019-06-09


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