Stem Cell Therapeutics Corp. TSX VENTURE: SSS
Aug 26, 2009 08:30 ET
Stem Cell Therapeutics Corp. Announces Second Quarter 2009 Financial Results
CALGARY, ALBERTA–(Marketwire – Aug. 26, 2009) – Stem Cell Therapeutics Corp. (“SCT”) (TSX VENTURE:SSS) today announced its financial results for the period ended June 30, 2009.
Highlights from the second quarter of 2009 and up to August 26, 2009
– May 16, 2009, SCT received a formal letter from the FDA confirming immediate removal of the clinical hold placed on the Phase IIb stroke trial, September 18, 2008. This allowed SCT to commence the recruitment of patients under an amended protocol using NTx®-265 for the Company’s Phase IIb clinical trial treating acute ischemic stroke.
– On July 20, 2009, SCT received a No Objection Letter (“NOL”) from Health Canada for the dose response designed modified REGENESIS protocol using NTx®-265 for a Phase IIb clinical trial treating acute ischemic stroke.
– On July 21, 2009, SCT received an NOL from the Drug Controller General of India (“DCGI”) to initiate the Phase IIb acute ischemic stroke trial.
– On July 27, 2009, the Company announced results from a meta-analysis of the combined BETAS Phase IIa clinical stroke trial data and REGENESIS Phase IIb clinical stroke trial data. At the time the clinical hold was placed on the REGENESIS Phase IIb trial, seven patients had been recruited, and subsequently they completed their 90-day evaluation period. Because this trial was placebo controlled, patients received either placebo or NTx®-265 and so could be combined with patient data from the non-placebo controlled BETAS Phase IIa trial where patients only received NTx®-265. By performing this type of statistical analysis, the Company was able to compare the combined data from 19 patients: 14 of which received drug (12 from BETAS Phase IIa and 2 from REGENESIS Phase IIb) and 5 patients who received placebo (all from REGENESIS Phase IIb). A decrease in the National Institute of Health Stroke Score (“NIHSS”) represents an improvement in a patient’s functionality, and importantly for a recovering patient, a decrease of 4 units in the NIHSS scale is considered a clinically relevant improvement. Of the 5 patients who received placebo, the average NIHSS actually increased by +0.7 points and out of the 14 patients who received NTx®-265, the NIHSS decreased by 8.1 points. The p-value from this meta-analysis was less than 0.0001, statistically significant.
– On August 4, 2009, the Company announced a presentation by Dr. Alan Moore, President and CEO, at the Advanced Technology Applications for Combat Casualty Care (“ATACCC”) 2009 conference which is the U.S. Department of Defense’s premier scientific meeting. Dr. Moore discussed patient recovery from brain injury by pharmacological (‘drug-induced’) activation of endogenous neural adult stem cells in traumatic brain injury (“TBI”) and stroke.
– Pursuant to an early warrant exercise incentive program that closed on August 7, 2009, warrant holders exercised 1,878,000 warrants for the same number of common shares and provided the Company with $300,480 in proceeds.
– On August 11, 2009, SCT announced enrollment of the first patient in its modified REGENESIS Phase IIb acute ischemic stroke trial. The modified REGENESIS trial is a double-blind, randomized, placebo-controlled Phase IIb clinical trial for SCT’s lead program, NTx®-265, for the treatment of acute ischemic stroke. This first patient was enrolled by the clinical team of Dr. Vijaya Pamidimukkala from the Lalitha Super Specialties Hospital Pvt Ltd in Guntur, Hyderabad, A.P.
The Company’s loss for the six month period ended June 30, 2009 decreased by $1,018,030 to $1,873,995 ($0.01 per common share) from the loss of $2,892,025 ($0.03 per common share) reported for the six month period ended June 30, 2008. The primary reasons for the decrease in loss were decreases in research and development costs, general and administration expenses, management and consulting fees and deemed interest charges offset by a decrease in interest income earned during the period.
As of June 30, 2009, the Company’s working capital (current assets minus current liabilities) was $4,241,743 ($5,803,377 as of December 31, 2008).
Outstanding securities as of August 25, 2009 are 134,680,497 common shares, 17,097,000 common share purchase warrants, and 11,002,500 common share options.
Dr. Alan Moore, President and CEO of SCT, commented as follows:
“We are excited to have commenced the modified REGENESIS Phase IIb acute ischemic stroke trial. Due to the cost cutting measures initiated by the Company in the first quarter of this year, we have managed to preserve sufficient capital to complete the modified REGENESIS Phase IIb stroke trial. We anticipate completion of the recruitment phase of the stroke trial by the end of this year and the release of the top-line data by the first quarter of 2010.”
The Company is also announcing that an aggregate of 960,000 stock options will be issued to SCT’s officers and Board of Directors on Friday August 28th based on the closing price of Thursday August 27th. These Options are being granted to those who voluntarily rolled back their salaries as part of the cost-cutting initiative announced earlier this year. These options were awarded in accordance with the Company’s Stock Option Plan.
About Stem Cell Therapeutics Corp.: Stem Cell Therapeutics Corp. is a Canadian public biotechnology company (TSX VENTURE: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 brain and nerve function lost due to disease or injury. The Company’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.