Neuralstem, Inc. (NYSE Amex: CUR) today provided a financial and business update for the third quarter ended September 30, 2009.
For the third quarter of 2009, the Company reported a net loss of $5,096,983, or $0.15 per share, compared with a net loss of $3,177,957 or $0.10 per share, for the comparable 2008 period. The increase was due to a non-cash charge related to a change in accounting for certain warrants, offset in part by reductions in other expense categories. Net loss attributable to common stockholders for the first nine months of 2009 was $7,380,751 or $0.22 per share, compared with $8,410,081, or $0.26 per share, for the comparable period in 2008, resulting from a year to date gain in accounting for warrants, partially offset by increases in non-cash stock-based compensation expense, R&D and legal fees.
Cash, cash equivalents and short-term marketable securities at September 30, 2009 totaled approximately $2.4 million, compared with approximately $4.9 million at December 31, 2008. As of September 30, 2009, the Company estimated that cash on hand would be sufficient to meet its operating needs into the first quarter of 2010, including estimated costs associated with the clinical trials for its ALS programs planned for commencement in the U.S. in 2010.
For the nine months ended September 30, 2009, cash used in operating activities totaled $3,613,084, a decrease of $1,118,358 or 24% compared to the same period in the prior year, primarily attributable to an increase of short term financing by vendors, employees and other service providers and a reduction in spending, particularly in research.
Clinical Program, Patent and General Business Update
In September the U.S. Food and Drug Administration (FDA) approved Neuralstem’s Investigational New Drug (IND) application to commence a Phase I trial to treat Amyotrophic Lateral Sclerosis (ALS or Lou Gehrig's disease) with its spinal cord stem cells. The Company expects to begin trials in the first quarter of 2010.
Neuralstem CEO and President, Richard Garr, stated, "The beginning of our clinical trial program is a major step toward achieving Neuralstem's goal of treating ALS, a fatal neurodegenerative disease for which currently there is no effective treatment or cure. While this trial aims to primarily establish safety and feasibility data in treating ALS patients, we also hope to be able to measure a slowing down of the ALS degenerative process. This trial will be in the extremely capable hands of Dr. Eva L. Feldman, M.D., Ph.D., Director of the University of Michigan Health System ALS Clinic and the Program for Neurology Research & Discovery, and Dr. Jonathan Glass, Director of the Emory Neuromuscular Laboratory and Director of the Emory ALS Center, both of whom are world-renowned for their study and treatment of ALS patients. We believe that there is no better team to conduct this study for us," said Garr. Their participation is subject to formal IRB approval by their institutions.
The Company also announced that it has received notice of allowance from the United States Patent and Trademark Office (USPTO) for its patent entitled “Transplantation of Human Neural Cells For Treatment Of Neurodegenerative Conditions,” number 11/281,640.
“We are gratified to add this important core technology patent to our portfolio,” said Neuralstem President & CEO Richard Garr. “The transplantation of our neural stem cells to treat degenerative conditions of the nervous system is at the heart of Neuralstem’s mission.” “Most importantly,” said Neuralstem Chief Scientific Officer, Dr. Karl Johe, “the claims in this patent cover the manufacturing process of our future products from all regions of the human central nervous system (brain and spinal cord) through July of 2026.”
In August the company reported that its Exchange listing compliance plan submitted in July had been accepted by the NYSE AMEX LLC (the Exchange). The Company outlined a plan for regaining compliance and in accepting Neuralstem’s plan, the Exchange has granted the Company an extension until December 6, 2010 to become compliant.
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