"During the quarter, the Company's primary focus was on the U.S. regulatory strategy and commercialization of Toraymyxin(TM) as an effective treatment for severe sepsis. We completed the protocol design for a clinical trial and we are evaluating a number of strategic and financial options that would allow us to start the trial in the first half of 2010," said
Financial Review
For the third quarter ended
Operating expenses for the third quarter ended
For the third quarter ended
Cash and short term investments as at
About Spectral Diagnostics
Spectral is a leader in the battle against sepsis. Spectral's lead product is its Endotoxin Activity Assay (EAA(TM)), the only FDA cleared assay for the measurement of endotoxin. With the growing awareness for the role of endotoxemia in sepsis and the increasing number of therapies being developed to treat endotoxemia, Spectral is well-positioned to promote the adoption of the EAA(TM), which can be used to identify patients, enable therapeutics and monitor treatment. Spectral is listed on TSX under the symbol SDI.
Forward-looking statement
Information in this news release that is not current or historical factual information may constitute forward-looking information within the meaning of securities laws. Implicit in this information, particularly in respect of the future outlook of Spectral and anticipated events or results, are assumptions based on beliefs of Spectral's senior management as well as information currently available to it. While these assumptions were considered reasonable by Spectral at the time of preparation, they may prove to be incorrect. Readers are cautioned that actual results are subject to a number of risks and uncertainties, including the availability of funds and resources to pursue R&D projects, the successful and timely completion of clinical studies, the ability of Spectral to take advantage of business opportunities in the biomedical industry, the granting of necessary approvals by regulatory authorities as well as general economic, market and business conditions, and could differ materially from what is currently expected.
The TSX has not reviewed and does not accept responsibility for the adequacy or accuracy of this statement. Spectral Diagnostics Inc. Balance Sheets - unaudited As at September 30, 2009 and December 31, 2008 ------------------------------------------------------------------------- (in thousands of dollars) 2009 2008 $ $ Assets Current assets Cash and cash equivalents 3,122 297 Short-term investments - 4,000 Accounts receivable 688 860 Inventories 207 203 Prepaid expenses 68 42 ----------------------- 4,085 5,402 Property, plant and equipment 452 493 Commercial instruments 99 132 Purchased technology and trademarks 706 1,058 ----------------------- 5,342 7,085 ----------------------- ----------------------- Liabilities Current liabilities Accounts payable and accrued liabilities 305 540 Deferred revenue 193 322 Convertible notes payable 2,295 2,172 ----------------------- 2,793 3,034 ----------------------- Shareholders' Equity Common shares 2,524 2,524 Other equity 5,748 5,716 Deficit (5,723) (4,189) ----------------------- 2,549 4,051 ----------------------- 5,342 7,085 ----------------------- ----------------------- Spectral Diagnostics Inc. Statements of Operations, Comprehensive Loss and Deficit - unaudited For the nine months ended September 30, 2009 and 2008 ------------------------------------------------------------------------- (in thousands of dollars, except share and per share data) 3 Months Ended 9 Months Ended September 30 September 30 2009 2008 2009 2008 $ $ $ $ Sales 815 701 2,433 2,150 Cost of sales 232 171 582 560 ----------------------- ------------------------ Gross margin 583 530 1,851 1,590 ----------------------- ------------------------ Operating expenses Selling, general and administrative 748 729 2,566 2,295 Amortization 155 160 478 478 Foreign exchange loss (gain) 59 (28) 111 (26) Stock-based compensation 32 22 32 65 Research and product development, net of tax credits 5 4 41 29 ----------------------- ------------------------ 999 887 3,228 2,841 ----------------------- ------------------------ Loss before the following (416) (357) (1,377) (1,251) Interest expense on convertible notes payable (41) (41) (123) (123) Other net investment (loss) income 28 66 (34) 175 ----------------------- ------------------------ Loss and comprehensive loss for the period (429) (332) (1,534) (1,199) Deficit - Beginning of period (5,294) (3,554) (4,189) (2,687) ----------------------- ------------------------ Deficit - End of period (5,723) (3,886) (5,723) (3,886) ----------------------- ------------------------ ----------------------- ------------------------ Basic and diluted loss per common share (0.01) (0.01) (0.06) (0.05) ----------------------- ------------------------ ----------------------- ------------------------ Weighted average number of common shares outstanding 24,118,424 24,118,424 24,118,424 24,118,424 ----------------------- ------------------------ ----------------------- ------------------------ Spectral Diagnostics Inc. Statements of Cash Flows - unaudited For the nine months ended September 30, 2009 and 2008 ------------------------------------------------------------------------- (in thousands of dollars) 3 Months Ended 9 Months Ended September 30 September 30 2009 2008 2009 2008 $ $ $ $ Cash provided by (used in) Operating activities Loss and comprehensive loss for the period (429) (332) (1,534) (1,199) Items not affecting cash Amortization 155 160 478 478 Amortization of commercial instruments included in cost of sales 22 6 65 18 Stock-based compensation expense 32 22 32 65 Interest on convertible notes payable 41 41 123 123 Unrealized loss on short-term investments - - 91 - Changes in non-cash working capital (54) 139 (93) (28) ----------------------- ------------------------ (233) 36 (838) (543) ----------------------- ------------------------ Financing activities Bank indebtedness - (195) - - ----------------------- ------------------------ Investing activities Purchase of property, plant and equipment (31) (32) (85) (147) Purchase of commercial instruments (7) - (32) (22) Decrease in short-term investments 2,945 359 3,909 258 Decrease in deferred revenue (43) (3) (129) (11) ----------------------- ------------------------ 2,864 324 3,663 (78) ----------------------- ------------------------ Increase (decrease) in cash and cash equivalents during the period 2,631 165 2,825 (465) ----------------------- ------------------------ Cash and cash equivalents - Beginning of period 491 8 297 638 ----------------------- ------------------------ Cash and cash equivalents - End of period 3,122 173 3,122 173 ----------------------- ------------------------ ----------------------- ------------------------
%SEDAR: 00002006E
For further information: For further information: Dr. Paul Walker, President & CEO, (416) 626-3233 ex. 2100; Casey Gurfinkel, Investor Relations, (416) 815-0700 ext. 283, [email protected]
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