Six Months ended June 30, 2005 and 2004 Total operating expenses decreased by $790,149 or 9%, from $8,848,353 in 2004 to $8,058,204 in 2005. With the completion of the pivotal dexanabinol trial in TBI and the decision to discontinue efforts for this indication, resources have been allocated to pre-clinical activities for cannabinor in preparation of beginning human clinical trials in the third quarter of 2005. The Company incurred higher compensation expenses for the deferred compensation from the September 2004 Retention Award Agreements and higher professional fees consisting of accounting and legal fees and higher insurance cost as discussed below. Major differences in year-to-date operating expenses year–over-year include decreased costs for both the Phase II clinical trials of dexanabinol as a preventative agent against cognitive impairment in CABG operations and the Phase III for TBI which completed enrollment by mid-year 2004. Cannabinor toxicology and other preclinical work has continued in the second quarter of 2005 along with scale up manufacturing and technology transfer to the active pharmaceutical ingredient supplier. The Company considers major research & development projects to be those projects that have reached at least Phase II level of clinical development. The Company’s Phase II project is the development of dexanabinol as a preventative agent against the cognitive impairment that can follow CABG surgery. During the first half of 2005, the gross cost of development and review was approximately $0.6 million. Total costs since the CI-CABG project entered Phase II development in 2003 through June 30, 2005 were $3.0 million. The Company is evaluating various strategies regarding development of this product and will make its determination of direction in the second half of 2005. To bring this product to the FDA for approval would require extensive additional testing in both Phase II and Phase III trials and there is no assurance the product could achieve regulatory approval and commercialization. Gross expenses for other research and development projects in early stages of development for the first two quarters of 2005 and 2004 were $3,509,373 and $925,064, respectively. Over 75% of the spending in both 2005 and 2004 was related to cannabinor and other CB2 compounds. Research & development (R&D) gross expenses decreased by $2,459,487 or 33% from $7,505,083 in 2004 to $5,045,236 in 2005 due to a reduction in clinical activity. The Company recorded research and development grant receivables from the Office of the Chief Scientist of Israel’s Ministry of Industry and Trade of $731,455 and $1,707,145 during the first two quarters of 2005 and 2004, respectively, which reduced the research and development expenses. Total research and development expenses, net of grants, decreased by 1,484,157 or 26% from $5,797,938 in 2004 to $4,313,781 in 2005. General and administrative expenses increased by $780,401 or 28%, from $2,750,345 in 2004 to $3,530,746 in 2005. The increase in general and administrative expenses is due to higher compensation, professional fees, and insurance by $555,508, $542,911, and $211,222 respectively, in the first two quarters of 2005 compared to the first two quarters of 2004. The decrease in general and administrative expenses is due to lower consultant expenses by $493,765 and savings from the Company’s cost containment efforts in the first half of 2005 compared to the first half of 2004. The increase in compensation is attributed to the amortization of deferred compensation related to General & Administration from the Retention Award Agreements in the amount of $551,471 which commenced in the third quarter of 2004. The higher professional fees in 2005 are attributed to increased accounting fees related to Sarbanes-Oxley compliance and legal fees related to the class action suits. The decrease in consulting is attributed to a non-cash charge of approximately $403,000 for extending the stock option exercise period to the Company’s former chief financial officer which was incurred in 2004 and no costs incurred in 2005 coupled with reduced pre-marketing consulting in 2005 vs. 2004. The increase in insurance is attributable to higher insurance rates. Depreciation and amortization expenses decreased by $86,393, or 29%, from $300,070 in 2004 to $213,677 in 2005. The decrease is due to fixed assets which have become fully depreciated. Other income (expense), net, increased by $13,775,042 from an expense of $2,377,749 in 2004 to income of $11,397,293 in 2005. Income of $10,725,688 was recognized for the net payment received from B&L in the first quarter of 2005. Interest expense decreased by $2,324,203 to $163,372 in 2005 from $2,487,575 in 2004. The decrease in 2005 interest expense is a result of the substantially reduced average outstanding balance during the first half of 2005 of the September 2003 Convertible Debentures. This debt was fully repaid as of March 31, 2005. Interest income increased by $324,167, or 107%, to $627,016 in 2005 from $302,849 in 2004 as a result of a higher average cash balance. During the first half of 2005, the Company recorded in other income royalties of $20,491 compared with $4,754 in the first half of 2004 per the licensing agreement with Herbamed Ltd, a company controlled by Dr. Haim Aviv, the Company’s CEO. |