CALGARY, ALBERTA--(Marketwire - April 9, 2009) - Stem Cell Therapeutics Corp. (“SCT”) (TSX VENTURE:SSS) today announced its financial results for the period ended December 31, 2008.
Operating Highlights from 2008 and the period ending April 9, 2009:
- Received ‘May Proceed’ notification from the FDA for its Phase IIb clinical stroke trial and IND in April 2008
- Enrolled first patient in the Canadian REGENESIS Phase IIb stroke trial, announced May 2008
- Completed animal efficacy study for Multiple Sclerosis
- Completed traumatic brain injury animal study comparator
- Received positive review from the Data Safety & Monitoring Board to continue progress of the REGENESIS Phase IIb clinical stroke trial, September 2008
- Received ‘No Objection Letter’ from Health Canada for a Traumatic Brain Injury Trial, September 2008
- Received Letter from Health Canada and Verbal Request from the FDA to place a clinical hold on the REGENESIS Phase IIb stroke trial in Canada; triggered by an unrelated German study, September 2008
- Announced final payment in common shares to Transition Therapeutics Inc. to complete the intellectual property acquisition of Stem Cell Therapeutics Inc., October 2008
- Appointed Mr. Barry Herring as Chief Financial Officer and VP, Finance, January 2009
- Presented positive final results for the BETAS Phase IIa clinical safety study in stroke in February 2009, including all U.S. and Canadian patient data
2009 Objectives
- Receive FDA approval to proceed with REGENESIS or alternate strategy for the Phase IIb stroke trial; Q2 09
- Complete REGENESIS Phase IIb clinical stroke study; Q4 09
- Initiate and enrol patients in the U.S. IND approved Phase IIb clinical stroke study; H1 09
- Initiate and enrol patients in the Phase IIa clinical study for Traumatic Brain Injury; H2 09
- Initiate clinical Proof-of-Concept study for Multiple Sclerosis; H2 09
Dr. Alan Moore, President & CEO of SCT commented as follows:
“Looking back at 2008, the Company faced both exciting and trying times, all of which are part of drug development. We are looking forward to 2009 as being a clinically productive year.”
Capital Position
As of December 31, 2008, the working capital (current assets minus current liabilities) of the Company was $5,803,377 ($9,138,263 as of December 31, 2007).
Outstanding securities as of December 31, 2007 totaled 132,802,497 common shares, 25,912,500 common share purchase warrants and 7,481,103 common share options.
Financial Review
The Company’s loss for the year ended December 31, 2008 increased by $105,936 to $5,559,517 ($0.05 per common share) from the loss of $5,453,581 ($0.08 per common share) reported for the year ended December 31, 2007. The primary reason for the increase in loss was an increase in research and development and professional fees. The increase in these expenses was partially offset by the increase in foreign exchange gains, and interest income, as well as lower interest expense and general and administration expenses.
About Stem Cell Therapeutics Corp.: Stem Cell Therapeutics Corp. is a Canadian public biotechnology company (TSX-V: SSS) focused on the development and commercialization of drug-based therapies to treat central nervous system diseases. SCT is a leader in the development of therapies that utilize drugs to stimulate a patient’s own resident stem cells. The Company’s programs aim to repair neurological function lost due to disease or injury. SCT’s extensive patent portfolio of owned and licensed intellectual property supports the potential expansion into future clinical programs in numerous neurological diseases such as traumatic brain injury, multiple sclerosis, Huntington’s disease, Alzheimer’s disease, and ALS.
For further information on Stem Cell Therapeutics Corp., visit www.stemcellthera.com.
These securities have not been registered under the United States Securities Act of 1933, as amended, or the securities laws of any state, and may not be offered or sold within the United States or to, or for the account or benefit of U.S. persons unless an applicable exemption from U.S. registration requirements is available.
Except for historical information, this press release may contain forward-looking statements, which reflect the Company’s current expectation regarding future events. These forward-looking statements involve risk and uncertainties, which may cause but are not limited to, changing market conditions, the successful and timely completion of clinical studies, the establishment of corporate alliances, the impact of competitive products and pricing, new product development, uncertainties related to the regulatory approval process and other risks detailed from time to time in the Company’s ongoing quarterly and annual reporting.
