4SC Announces Financial Results for the First Quarter 2010
Highlights of the First Quarter 2010
- Phase II study commenced to assess the efficacy of resminostat in the indication Hodgkin's lymphoma - first patient recruited
- Commenced two Phase I studies with the multikinase inhibitor 4SC-203 and the Eg5 Inhibitor 4SC-205
- Colon cancer selected as the third indication for resminostat; initiated preparations for a Phase I/II study in combination with a standard chemotherapy (FOLFIRIregimen)
Dr Ulrich Dauer, CEO of 4SC, commented on the course of business: "In the first quarter of 2010, we continued our 2009 growth trajectory and drove forward our clinical activities. The excellent progress we made in the ongoing Phase II studies and the commencement of three new clinical programmes substantiate the consistent execution of our development strategy and reinforce our positioning as an attractive partner to biotech and pharmaceutical companies."
Overview of Quarterly Results:
In the first quarter of 2010, 4SC generated revenue of €0.3 million from research collaborations, down from €0.5 million for the same period in 2009. Total operating expenses came to €5.6 million, compared with €4.4 million in the prioryear quarter. This rise is largely attributable to an increase in research and development costs of around onethird to €4.5 million (first quarter of 2009: €3.4 million), which in turn is primarily due to the continued development of 4SC's product pipeline and the doubling of the number of ongoing clinical studies from three in the first quarter of 2009 to six at present.
The decline in revenue coupled with higher expenses yielded an operating loss of €5.3 million for the period from January to March 2010, contrasting with a loss of €3.9 million in the prioryear period. As anticipated, the net loss for the period rose to €5.3 million, up from €3.7 million in the first quarter of 2009.
At €-0.14, earnings per share remained virtually unchanged on the prioryear figure of €-0.13. Funds totalled €31.0 million as at 31 March 2010 (31 December 2009: €35.6 million).
Considerable Expansion of the Clinical
Pipeline 4SC further increased the value of its product pipeline in the first quarter of 2010 and recorded numerous positive developments in its clinical programmes. Three new clinical studies were initiated in the field of oncology in the first quarter alone. Specifically, one Phase II study with resminostat for treating Hodgkin's lymphoma (HL), one Phase I study with 4SC-203 in healthy volunteers and another Phase I study with 4SC-205 on patients with solid tumours or malignant lymphomas were initiated.
In January, with the commencement of the new Phase II study in HL, another potential indication was developed for the oncology compound resminostat, which is under evaluation for its efficacy against hepatocellular carcinoma (HCC) since last year. Also in Q1, preparations began for Phase I/II studies to examine resminostat for the treatment of patients with colon cancer, which is the third target indication chosen for this histone deacetylase (HDAC) inhibitor compound. The anticipated colon cancer study will evaluate the efficacy and tolerability of resminostat in combination with an established, frequently used form of chemotherapy, the FOLFIRI regimen, as a secondline treatment in patients with KRAS tumour mutations.
4SC also commenced two Phase I studies in the first quarter of 2010. In January 2010, dosing of the first healthy volunteers commenced for the multikinase inhibitor 4SC-203. February saw the treatment of the first cancer patient with the Eg5 kinesin inhibitor 4SC-205.
Due to the recent expansion of the product pipeline, 4SC's portfolio currently comprises a total of four drugs in six clinical studies as well as two further drug candidates in preclinical development. Several of these drug products will reach key milestones in the short to medium term. Vidofludimus is due to report results for the Phase IIa study in inflammatory bowel disease (IBD) in the second half of 2010, while the results from the Phase IIb study in rheumatoid arthritis (RA) are expected at the end of 2010. Phase I results for the compound 4SC-203 are also anticipated towards the end of 2010. The Phase II trials in HCC and HL with resminostat will continue to advance in 2010 and are expected to yield valueenhancing clinical results in 2011, the same as for 4SC-205. In addition, the launch of the colon cancer study with resminostat and the preparation of 4SC-202 for clinical development will enhance the sustainability of the Company's product pipeline in the next twelve months.
The complete quarterly report will be available from 9am today at www.4sc.com/investors.
The senior management team of 4SC will host a conference call at 3pm CET (9am EST) today to inform about the results for the quarter and all important developments in the reporting period.
About 4SC AG
4SC AG (ISIN DE0005753818) is a drug discovery and development company focused on autoimmune and cancer indications. Vidofludimus (4SC-101), a small molecule, is currently in a Phase IIb study in rheumatoid arthritis and a Phase IIa exploratory study in inflammatory bowel disease. The company's lead oncology compound, resminostat (4SC-201), a pan histone deacetylase (HDAC) inhibitor, is in Phase II trials in hepatocellular carcinoma and Hodgkin's lymphoma. Two further oncology compounds, 4SC-203 and 4SC-205 are in Phase I studies. 4SC develops drug candidates until proofofconcept 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.