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4SC AG — Earnings Release 2011
May 10, 2011
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Earnings Release
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Corporate | 10 May 2011 07:30
4SC Announces Financial Results for the First Quarter 2011
4SC AG / Key word(s): Quarter Results
10.05.2011 / 07:30
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
MC Services
Raimund Gabriel
Tel.: +49 (0) 89 21 02 28 – 30
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: | [email protected] |
| 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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