Stocks & Investing
Stocks and Investing
Stocks and Investing
Tue, April 12, 2011
Mon, April 11, 2011 SPECTRAL DIAGNOSTICS REFILES THIRD QUARTER UNAUDITED INTERIM FINANCIAL STATEMENTS
TORONTO, April 11 /CNW/ - Spectral Diagnostics Inc., (TSX: SDI), a Phase III company developing the first theranostic treatment for severe sepsis and septic shock, today announced that it has refiled, on SEDAR, its unaudited interim financial statements for the nine month period ended September 30, 2010 to include specific disclosure that these interim financial statements have not been subject to a review by the Company's auditors. Other than this disclosure, there are no changes to these unaudited interim financial statements.
About Spectral Diagnostics
Spectral is a Phase III company seeking U.S. FDA approval for its lead theranostics product for the treatment for severe sepsis and septic shock. Toraymyxin is a therapeutic hemoperfusion device that removes endotoxin, which can cause sepsis, from the bloodstream. Directed by the Company's Endotoxin Activity Assay (EAA™), the only FDA cleared diagnostic for the risk of developing sepsis, Spectral's EUPHRATES trial is the world's first theranostics trial in the area of sepsis.
Toraymyxin has been approved for therapeutic use in 18 countries, and has been used safely and effectively in more than 80,000 patients to date. In March, 2009, Spectral obtained the exclusive development and commercial rights in the U.S. for Toraymyxin, and in November, 2010, signed an exclusive distribution agreement for this product in Canada. More than 250,000 patients are diagnosed with severe sepsis and septic shock in North America each year, representing a greater than $1 billion market opportunity for Spectral. Spectral is listed on the Toronto Stock Exchange under the symbol SDI.
For further information please visit [ www.spectraldx.com ]
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, 2010 and December 31, 2009
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(in thousands of dollars)
| 2010 $ | 2009 $ | |||||||||||||||||
| Assets | ||||||||||||||||||
| Current assets Cash and cash equivalents Accounts receivable Inventories Prepaid expenses | | | | | | | | | | | | 16,353 766 251 85 | | 2,944 781 123 45 | ||||
| 17,455 | 3,893 | |||||||||||||||||
| Property, plant and equipment | 406 | 457 | ||||||||||||||||
| Commercial instruments | 74 | 94 | ||||||||||||||||
| Purchased technology and trademarks | 736 | 588 | ||||||||||||||||
| 18,671 | 5,032 | |||||||||||||||||
| Liabilities | ||||||||||||||||||
| Current liabilities Accounts payable and accrued liabilities Current portion of convertible notes payable | | | | | | | | | | | | 784 1,319 | | 1,077 2,336 | ||||
| 2,103 | 3,413 | |||||||||||||||||
| Deferred revenue | 157 | 254 | ||||||||||||||||
| 2,260 | 3,667 | |||||||||||||||||
| Shareholders' Equity | ||||||||||||||||||
| Common shares | 21,281 | 2,524 | ||||||||||||||||
| Other equity | 6,586 | 5,794 | ||||||||||||||||
| Deficit | (11,456) | (6,953) | ||||||||||||||||
| 16,411 | 1,365 | |||||||||||||||||
| 18,671 | 5,032 | |||||||||||||||||
These unaudited interim financial statements have been prepared by management of Spectral Diagnostics Inc. and have not been reviewed by the Company's auditors.
Spectral Diagnostics Inc.
Statements of Operations, Comprehensive Loss and Deficit - unaudited
For the nine months ended September 30, 2010 and 2009
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(in thousands of dollars, except share and per share data)
| 3 Months Ended September 30 | 9 Months Ended September 30 | ||||||
| 2010 $ | 2009 $ | 2010 $ | 2009 $ | ||||
| Sales | 722 | 815 | 2,148 | 2,433 | |||
| Cost of sales | 138 | 232 | 457 | 582 | |||
| Gross margin | 584 | 583 | 1,691 | 1,851 | |||
| Operating expenses Selling, general and administrative Clinical trial Service fees Amortization Foreign exchange loss Stock-based compensation Research and product development, net of tax credits | 850 595 250 155 35 - - | 707 41 - 155 59 32 5 | | 2,511 1,563 750 466 48 792 24 | 2,261 305 - 478 111 32 41 | ||
| 1,885 | 999 | 6,154 | 3,228 | ||||
| Loss before the following | (1,301) | (416) | (4,463) | (1,377) | |||
| Interest on convertible notes payable | (24) | (41) | (83) | (123) | |||
| Other net investment income (loss) | 35 | 28 | 43 | (34) | |||
| Loss and comprehensive loss for the period | (1,290) | (429) | (4,503) | (1,534) | |||
| Deficit - Beginning of period | (10,166) | (5,294) | (6,953) | (4,189) | |||
| Deficit - End of period | (11,456) | (5,723) | (11,456) | (5,723) | |||
| Basic and diluted loss per common share | (0.02) | (0.01) | (0.07) | (0.06) | |||
| Weighted average number of common shares outstanding | 75,844,484 | 24,118,424 | 64,281,721 | 24,118,424 | |||
These unaudited interim financial statements have been prepared by management of Spectral Diagnostics Inc. and have not been reviewed by the Company's auditors.
Spectral Diagnostics Inc.
Statements of Cash Flows - unaudited
For the nine months ended September 30, 2010 and 2009
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(in thousands of dollars)
| 3 Months Ended | 9 Months Ended | |||||||||
| September 30 | September 30 | |||||||||
| 2010 $ | 2009 $ | 2010 $ | 2009 $ | |||||||
| Cash provided by (used in) | ||||||||||
| Operating activities Loss and comprehensive loss for the period Items not affecting cash | (1,290) | | (429) | | (4,503) | | (1,534) | |||
| Amortization Amortization of commercial instruments included in cost of sales Stock-based compensation expense Interest on convertible notes payable Unrealized loss on short-term investments | 155 10 - 24 - | 155 22 32 41 - | | 466 58 792 83 - | 478 65 32 123 91 | |||||
| Changes in non-cash working capital | 150 | (54) | (1,546) | (93) | ||||||
| (951) | (233) | (4,650) | (838) | |||||||
| Financing activities Proceeds on issue of private placement Proceeds on exercise of stock options Settlement of convertible notes payable | - 17 - | | - - - | | 17,608 49 1,100 | | - - - | |||
| 17 | - | 18,757 | - | |||||||
| Investing activities Purchase of property, plant and equipment Purchase of commercial instruments Purchase of technology and trademarks Decrease in short-term investments Decrease in deferred revenue | (6) (11) - - (32) | | (31) (7) - 2,945 (43) | | (61) (38) (502) - (97) | | (85) (32) - 3,909 (129) | |||
| (49) | 2,864 | (698) | 3,663 | |||||||
| Increase (decrease) in cash and cash equivalents during the period | (983) | 2,631 | 13,409 | 2,825 | ||||||
| Cash and cash equivalents - Beginning of period | 17,336 | 491 | 2,944 | 297 | ||||||
| Cash and cash equivalents - End of period | 16,353 | 3,122 | 16,353 | 3,122 | ||||||
| Non cash working capital and financing activities Decrease in current portion of convertible notes payable Settlement of convertible notes payable | - - | | - - | | (1,100) 1,100 | | - - | |||
These unaudited interim financial statements have been prepared by management of Spectral Diagnostics Inc. and have not been reviewed by the Company's auditors.
