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 year ended 31 December 2010.

The year 2010 was a highly successful one for 4SC. As the year progressed, the Company made significant advances in its entire clinical product portfolio and reported promising results from its ongoing Phase II development programmes with resminostat in the field of oncology and vidofludimus for the treatment of autoimmune diseases. By the end of the year, 4SC had a robust and mature product pipeline with no fewer than four small-molecule compounds in six clinical studies and two more preclinical programmes.

Highlights in 2010:

  • Proof-of-concept for vidofludimus in inflammatory bowel disease - positive Phase IIa results in the ENTRANCE study
  • Completion of patient recruitment for vidofludimus in the Phase IIb COMPONENT study in rheumatoid arthritis
  • Positive interim results for resminostat from the Phase II SHELTER study for treating patients with hepatocellular carcinoma and from the Phase II SAPHIRE study for the treatment of Hodgkin's lymphoma
  • Expansion of the pipeline and its sustainability through the launch of two new Phase I programmes with the multi-kinase inhibitor 4SC-203 as well as the oral Eg5 kinesin spindle protein inhibitor 4SC-205 in patients with solid tumours and malignant lymphomas
  • Cash balance of EUR17.6 million at 31 December 2010

Dr Ulrich Dauer, CEO of 4SC, commented on the course of business: '2010 was a highly successful year for us. We sharpened our profile as a leading developer of targeted small-molecule therapies for autoimmune diseases and cancer and underpinned our success with solid data. We hope to continue this positive momentum in the new financial year. 2011 will be a decisive year for us: we expect results from three Phase II studies with our two lead compounds - resminostat in oncology and vidofludimus for the treatment of autoimmune diseases.'

Financial results in 2010

In the 2010 financial year, 4SC generated total revenue of just under EUR1.0 million. This figure was reduced compared with previous year's figure of EUR1.9 million due to the concentration of resources on the implementation of 4SC's own development programmes.

The initiation of three more clinical studies and the progress made in the existing clinical development programmes increased research and development expenses, as expected, from EUR14.2 million in 2009 to EUR17.0 million in 2010. Administrative costs rose slightly year-on-year from EUR3.4 million to EUR3.6 million.

The increase in development costs raised the net loss to EUR20.1 million in 2010 from EUR16.1 million in 2009.

As a result of the capital increase implemented at the end of 2009, the number of shares in the reporting period was 38,502,739, up from an average of 29,752,739 in the previous year. The loss per share fell accordingly to EUR0.52, compared with EUR0.54 in 2009.

Cash flows

At 31 December 2010, 4SC AG had funds of EUR17.6 million (2009: EUR35.6 million). Cash and cash equivalents amounted to just under EUR5.0 million at the reporting date. Other funds of EUR12.7 million were invested in current financial assets.

While no capital measures took place in 2010, 4SC successfully completed a capital increase in February 2011, shortly after the end of the reporting period. The new shares were placed exclusively with new institutional investors from Germany, the Benelux countries, Scandinavia and the United States. This increased the free float from around 19.4% to approximately 26.0%. By issuing 3,452,647 new shares at EUR3.40 per share, the Company generated gross issue proceeds of around EUR11.74 million.

Outlook

In 2011, 4SC anticipates final Phase II data from three clinical studies and, with this, the potential proof-of-concept for vidofludimus in rheumatoid arthritis as well as for resminostat in the two indications of hepatocellular carcinoma and Hodgkin's lymphoma. This will boost the value of the products and increase the Company's enterprise value.

Mid-2011, 4SC plans to present top line data from the Phase IIb COMPONENT study with vidofludimus in rheumatoid arthritis. Positive results were already reported in November 2010 for the Phase IIa study in inflammatory bowel disease.

In its oncology portfolio, 4SC expects results from two Phase II studies for resminostat in 2011 in the indications Hodgkin's lymphoma and hepatocellular carcinoma. Initial encouraging data from these two studies were published at the end of 2010.

A further Phase I/II clinical trial called SHORE was commenced in January 2011 to evaluate the same compound in colon cancer patients with KRAS mutations.

Two more Phase I programmes strengthen the clinical oncology pipeline in 2011. Positive Phase I data were already reported for 4SC-203 in January 2011. Results for 4SC-205 are also expected in the course of 2011.

Under the Company's current plans, research and development costs in 2011 and 2012 will remain at more or less the same level as in 2010. As a result, 4SC anticipates posting a loss once again for both years.

4SC reached important drug development milestones in 2010. In connection with the successful capital increase implemented in February 2011, 4SC believes it has a very strong position from which to achieve its set development goals for the coming months as well as to negotiate possible licensing partnerships for one or several of its programmes.

The complete annual financial report will be available for download at www.4sc.com/Investors from 8:00 am CET.

Telephone Conference and Webcast

4SC will host a telephone conference at 3:00 pm CET (9:00 am EST) today. The senior management team will inform about the key developments in financial year 2010 and will provide an update on the development programmes.

Access to the presentation slides can be obtained at: http://4sc290311-live.cyber-presentation.de

To participate in the telephone conference, please use the following data:

Date: 29 March 2011Time: 3:00 pm CET (9:00 am EST)Dial-in numbers: 0800 10 12 072 (Germany)0800-358-0886 (UK)1-877-941-6012 (USA)+49 6103 485 3001 (other countries)

Conference ID: 4421825

Approximately two hours after the live presentation, an audio replay of the conference will be available on the 'investors' section of www.4sc.com.

About 4SC

4SC AG (ISIN DE0005753818) discovers and develops targeted small molecules for autoimmune and cancer indications. Vidofludimus (4SC-101), an oral IL-17 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. 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.

  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@4sc.com

Internet:

www.4sc.de

ISIN: DE0005753818 WKN: 575381 Listed: Regulierter Markt in Frankfurt (Prime Standard); Freiverkehr in Berlin, Düsseldorf, München, Stuttgart
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