Oct 26 2010
Karo Bio (STO:KARO) Secures Funding of Approx. MSEK 530 to Enable Clinical Phase III Studies of Eprotirome
The January-September period and third quarter 2010 in brief
• Net sales amounted to MSEK 0.0 (5.9), with MSEK 0.0 (1.5) in the third quarter
• Net loss was MSEK 113.4 (116.9), with a net loss of MSEK 34.4 (34.2) in the third quarter
• Loss per share was SEK 0.73 (0.92), with loss per share of SEK 0.22 (0.27) in the third quarter
• Cash flow from operating activities was MSEK -114.6 (-116.8), with a cash flow of MSEK -33.7 (-37.2) in the third quarter
• Cash and cash equivalents and other short-term investments totaled MSEK 116.2 (119.0) at the end of the period
• The company has chosen to initially develop its leading lipid-lowering candidate drug eprotirome for the treatment of high-risk patients with heterozygous familial hyper-cholesterolemia (HeFH)
• On August 26, Karo Bio presented the development plan for eprotirome at a seminar where professors Steven E. Nissen and Paul J.P. Kastelein held presentations and discussed the medical need for efficacious treatment of high-risk patients with HeFH
• Karo Bio's partner Merck has announced its decision to discontinue development of the drug candidate MK-6913 for the treatment of hot flashes. An interim analysis of data showed that the pre-defined efficacy criteria were not met. Merck is evaluating its options for future studies involving MK-6913
SIGNIFICANT EVENTS AFTER THE END OF THE REPORTING PERIOD
• Karo Bio has received scientific advice from the European Medicines Agency, EMA, after which the size of the investment for the planned phase III development program for eprotirome can be estimated to approx. MSEK 400
• Subject to the approval of shareholders at an EGM, the company has secured financing amounting to approx. MSEK 530 for implementing phase III studies for eprotirome:
- in part by entering into an Equity Credit Facility financing agreement of MUSD 35 (around MSEK 230) which the company is entitled to use to successively issue shares to the financier according to stipulated conditions for 36 months;
- in part through the implementation of a rights issue proposed by the board of directors of approx. MSEK 300, which is fully underwritten by Carnegie Investment Bank AB and other guarantors.
• The board of directors has summoned an extraordinary general meeting to be held on November 24 for decisions on the Equity Credit Facility and the rights issue as described above.