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and Trade of $0 and $238,123 during the third quarter of 2008 and 2007, respectively. The decline in research and development grants directly related to the decrease in the underlying eligible activity for the grants as the Company focused more research funds on the US based Phase 2b clinical trial for Dextofisopam. Total research and development expenses, net of grants, decreased by $174,769 or 7%, from $2,473,651 in 2007 to $2,298,882 in 2008. |
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In the quarter ended September 30, 2008, the Company advanced a Phase IIb trial of its lead compound, dextofisopam, in female IBS patients. The Phase IIb trial is expected to enroll approximately 480 patients in about 70 sites. Costs of $1,734,000 were incurred during the quarter in connection with the trial, comprising CRO-related activities and patient recruitment costs. During the second quarter, the Company engaged a second CRO to identify and manage additional sites. As the Company is currently behind its planned enrollment schedule, additional expenses were incurred in conducting a centralized advertising campaign to enhance patient enrollment. Dextofisopam was one of the compounds the Company obtained through the acquisition of Vela Pharmaceuticals Inc which closed in October 2006. The continued development of this compound through late-stage clinical testing will significantly increase the research and development expenses going forward. Patient enrollment in the Dextofisopam trial continues and is expected to be completed in the second half of 2009. |
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A Phase 2a clinical trial with the Company’s NanoEmulsion delivery technology for topical application of analgesic and anti-inflammatory agents commenced in June 2007 targeting 126 patients. The Company believes that it has sufficient patient data to measure efficacy and, given the typically slow recruitment encountered in the summer, the Company has decided to cease enrollment, complete those patients currently in screening, and evaluate and analyze the results of the 100+ patients who have completed the trial. |
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General and administrative expenses for the third quarter of 2008 decreased by $763,836, or 64%, from $1,200,594 in 2007 to $436,758 in 2008. The decline reflects decreases in virtually every general and administrative expense category. The primary reductions include a $468,120 reduction in payroll, a $92,902 reduction in consultant and professional fees and a reduction in BOD fees of $93,000. The decrease in payroll costs reflect the impact of the third and fourth quarter 2007 restructuring plans which have reduced the Company’s head count from 51 employees in March 2007 to 11 employees at the end of September 2008. The decrease in consulting and professional fees in 2008 result from a decline in legal costs from lower patent costs, a decline in investor relation costs, and a one time IRS section 382 tax analysis cost incurred in 2007. The decrease in the BOD meeting costs result from board members receiving Company common stock in lieu of cash payments. |
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Depreciation and amortization expenses decreased by $33,093, or 57%, from $57,946 in 2007 to $24,853 in 2008. The decrease is due to fixed assets which have become fully depreciated and the disposition of various depreciable assets in conjunction with the Company’s 2007 restructuring plans. |
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Other income (expense) net, decreased by $277,495 from $193,636 in other income in 2007 to $83,859 in other expense in 2008. The majority of the decrease is from decreased interest income of $155,642 from a decline in cash, cash equivalents and short term investments. In the third quarter of 2008 the Company recorded $122,580 in interest expense related to the issuance of $4,000,000 in convertible debentures issued on January 3, 2008. |
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No tax provision is required at this time since the Company expects to be in a tax loss position at year-end December 31, 2008 and has net operating losses from previous years. The Company has established a 100% valuation allowance against the deferred tax asset. |
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Nine Months ended September 30, 2008 and 2007 |
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Total operating expenses for the first nine months ended September 30, 2008 decreased by $4,725,607 or 35% from $13,709,777 in 2007 to $8,984,170 in 2008. |
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Research & development gross expenses decreased by $2,078,634 or 22% from $9,285,543 in 2007 to |