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SSS Sunvest Minerals Corp

0.035
0.00 (0.00%)
19 Jul 2024 - Closed
Delayed by 15 minutes
Share Name Share Symbol Market Type
Sunvest Minerals Corp TSXV:SSS TSX Venture Common Stock
  Price Change % Change Share Price Bid Price Offer Price High Price Low Price Open Price Shares Traded Last Trade
  0.00 0.00% 0.035 0.035 0.04 0 01:00:00

Stem Cell Therapeutics Corp. Announces Second Quarter 2008 Financial Results

27/08/2008 11:17pm

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Stem Cell Therapeutics Corp. ("SCT") (TSX VENTURE: SSS) today announced its financial results for the period ended June 30, 2008.

Selected Highlights

During the second quarter of 2008 and up to August 27, 2008, SCT achieved the following accomplishments:

- On April 23, 2008, SCT announced that the U.S. Food and Drug Administration has allowed its investigational new drug application (IND) to proceed. The IND-opening study is a U.S. double-blind, randomized, placebo-controlled Phase IIb clinical trial of its lead program, NTx(TM)-265, for the treatment of acute ischemic stroke. The FDA response allows initiation of the U.S. Phase IIb clinical trial in acute ischemic stroke, led by the Principle Investigator of the Phase IIa BETAS stroke trial, Dr. Steven C. Cramer, at the University of California, Irvine. Dr. Cramer is also the co-Lead Investigator of the Canadian Phase IIb REGENESIS trial along with Dr. Michael Hill at the Foothills Hospital, University of Calgary. We anticipate patient enrollment for the U.S. Phase IIb stroke study to begin in Q4 08 and to be complete in Q2 09.

- On May 28, 2008, SCT announced the enrollment of the first patient in its REGENESIS Phase IIb stroke trial. The REGENESIS trial is a double-blind, randomized, placebo-controlled Phase IIb clinical trial for SCT's lead program, NTx(TM)-265, for the treatment of acute ischemic stroke.

- On May 30, 2008, the Company announced the appointment of Thomas R. Franck to the Executive Team as Vice President of Commercial Planning. Mr. Franck is a 30-year veteran of Procter & Gamble and has extensive experience and skill as a sales and marketing director. His current focus on development projects will play a key role with SCT's pre-Phase III planning. Mr. Franck's knowledge will assist in managing our pre-launch professional relations as well as establish the valuation both of individual programs and the Company as a whole.

- On July 7, 2008, SCT announced the issuance of two keystone prolactin patents. The U.S. patent, numbered 7,393,830 and entitled "Prolactin induced increase in neural stem cell numbers" was issued July 1, 2008. The Australian patent, numbered 2002325711 and entitled "Prolactin induced increase in neural stem cell numbers and therapeutical use thereof" was issued January 10, 2008. These are the first patents to issue in this patent family. These patents cover the use of prolactin alone, as well as in combination with other therapeutics that augment recovery and therefore provide a broad base of protection. We have the exclusive right to the use of prolactin for treating neurodegenerative diseases and therefore have a strong foundation to develop many possible products using prolactin, either as a single therapeutic or in combination with other neurogenic agents.

- On July 28 2008, SCT announced the presentation of data from the phase I open labeled uncontrolled pharmacokinetic study of a single intra-muscular hCG dose in healthy male volunteers at the IX World Conference on Clinical Pharmacology and Therapeutics in Quebec City, Quebec. This study demonstrated for the first time that administering hCG systemically in man resulted in appreciable amounts of hCG in the central nervous system and established that drug would be present and available to signal neurogenesis during the time of an acute neurological injury. Additionally, two forms of hCG were compared, Pregnyl(TM) derived from human urine and Ovitrelle(TM) a recombinant form. These two forms of hCG demonstrated similar pharmacokinetics when administered peripherally, both in blood and cerebrospinal fluid.

Dr. Alan Moore, President and CEO, commented on the Phase IIb acute ischemic stroke trial as follows:

"We were very pleased to begin recruiting patients for the REGENESIS Phase IIb stroke trial in May of this year; however site initiation and patient enrollment have been slower to date than anticipated. As a result we are looking to do a portion of the trial in India. If we are successful in this regard then we may be able to meet our milestone of completing enrolment in the Phase IIb clinical stroke trial by the end of this year."

Upcoming 2008 Milestones

- Complete enrollment in the REGENESIS Phase IIb clinical stroke study for NTx(TM)-265

- Initiate and enroll patients in the Phase IIa clinical study for Traumatic Brain Injury

- Initiate and enroll patients in the U.S. IND approved Phase IIb clinical stroke study for NTx(TM)-265

- Complete animal efficacy studies for Multiple Sclerosis

Capital Position

As of June 30, 2008 the working capital (current assets minus current liabilities) of the Company was $6,515,537 ($9,138,263 as of December 31, 2007).

Outstanding securities as of June 30, 2008 and August 26, 2008 totaled 103,529,864 common shares, 6,000,000 class B shares, 25,912,500 common share purchase warrants and 7,930,556 common share options.

Financial Review

The Company's loss for the six month period ended June 30, 2008 increased by $802,835 to $2,892,025 ($0.03 per common share) from the loss of $2,089,190 ($0.03 per common share) reported for the six month period ended June 30, 2007. The primary reason for the change in the reported loss figure is the increase in research and development costs. The June 30, 2008 "Management Discussion and Analysis" provides further details on these operating results.

About NTx(TM)-265: NTx(TM)-265 is a therapeutic regimen of two approved and clinically well-defined drugs, human Chorionic Gonadotropin (hCG) and Erythropoietin (EPO), targeting the treatment of stroke. The twin objectives of the regimen are to stimulate the growth and differentiation of new neurons to replace the brain cells that were lost or damaged by the stroke, and importantly, to direct motor, visual and cognitive recovery after acute ischemic stroke. Animal studies have shown a significant recovery in motor function after receiving the NTx(TM)-265 regimen 24-48 hours post stroke. Encouraging clinical results in SCT's Phase IIa BETAS stroke trial were presented at the International Stroke Conference in February 2008, showing clinically relevant recovery in 8 of 8 patients who received the complete regimen. SCT is recruiting patients for the multi-centre, double-blind, placebo-controlled Phase IIb REGENESIS study for NTx(TM)-265 with primary endpoints of efficacy.

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 neurological 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 and multiple sclerosis.

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.

The TSX Venture Exchange does not accept responsibility for the adequacy or accuracy of this release.

Contacts: Stem Cell Therapeutics Corp. Alan Moore, PhD President and CEO (403) 245-5495 ext.224 Email: amoore@stemcellthera.com Stem Cell Therapeutics Corp. Chloe Douglas-Crampton Investor Relations (403) 245-5495 ext. 221 Email: crampton@stemcellthera.com Website: www.stemcellthera.com

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