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Share Name | Share Symbol | Market | Type |
---|---|---|---|
Spectral Medical Inc (PK) | USOTC:EDTXF | OTCMarkets | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
0.00 | 0.00% | 0.411 | 0.3614 | 0.3943 | 0.00 | 21:00:11 |
Spectral Diagnostics Inc., (TSX:SDI / OTCQX: DIAGF), a Phase III company developing the first theranostic treatment for patients with septic shock, today announced its unaudited financial results for the first quarter ended March 31, 2013.
First Quarter Highlights:
"During the past few months, we solidified our cash position and strengthened our existing collaborative relationship with Toray Industries," said Dr. Paul Walker, President and CEO of Spectral Diagnostics. "On the clinical front, we continued to steadily enroll patients into our pivotal Phase III trial and are now less than a year away from our second planned interim analysis of the trial data."
The second interim analysis will occur after 184 randomized patients have been followed for 28 days. At the second analysis, the trial's DSMB will advise Spectral on the trial's safety, efficacy or futility, with stopping rules in place for efficacy and futility. A sample size recalculation will be done if necessary. Management remains on track to disclose information from the second interim analysis in the first half of 2014.
Financial Review
Revenue for the three months ended March 31, 2013 was $708,000 compared to $676,000 for the same period in the preceding year, representing an increase of 4.7%.
Revenue was positively impacted by the revised terms of certain EAA™ distribution agreements that took effect during 2012. It is anticipated that revenue in 2013 will be consistent with levels achieved in 2012.
Operating costs for the three months ended March 31, 2013 were $2,807,000 compared to $2,976,000 in the first quarter of 2012. This represents a decrease of $169,000. The Company continues to maintain a low-cost operating structure and expects no material increase in non-clinical operating costs in 2013.
The Company concluded the first quarter of 2013 with cash, cash equivalents and short-term investment of $7,576,000compared to $10,562,000 as at December 31, 2012. On April 2, 2013, the Company closed a private placement for gross proceeds of $5.6 million. The cash balance immediately following the private placement was $12,955,000.
About Spectral Diagnostics
Spectral is a Phase III company seeking U.S. FDA approval for its lead theranostics product for the treatment of severe sepsis with 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 Japan and Europe, and has been used safely and effectively on more than 100,000 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 inCanada. 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, and on the OTCQX under the symbol DIAGF. For more information please visitwww.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. | ||||||||
Condensed Interim Statement of Financial Position | ||||||||
(in thousands of Canadian dollars) | ||||||||
March 31 2013 | December 31 2012 | |||||||
$ | $ | |||||||
Unaudited | Audited | |||||||
Assets | ||||||||
Current assets | ||||||||
Cash and cash equivalents | 2,403 | 5,425 | ||||||
Short-term investment | 5,173 | 5,137 | ||||||
Trade and other receivables | 673 | 590 | ||||||
Inventories | 418 | 277 | ||||||
Prepayments | 647 | 226 | ||||||
9,314 | 11,655 | |||||||
Non-current assets | ||||||||
Property, plant and equipment | 578 | 497 | ||||||
Intangible assets | 428 | 434 | ||||||
1,006 | 931 | |||||||
Total assets | 10,320 | 12,586 | ||||||
Liabilities | ||||||||
Current liabilities | ||||||||
Trade and other payables | 1,672 | 1,913 | ||||||
Deferred revenue | 74 | 99 | ||||||
Total liabilities | 1,746 | 2,012 | ||||||
Equity | ||||||||
Share capital | 27,101 | 27,101 | ||||||
Contributed surplus | 3,864 | 3,864 | ||||||
Other equity reserves | 8,337 | 8,260 | ||||||
Deficit | (30,728) | (28,651) | ||||||
Total equity | 8,574 | 10,574 | ||||||
Total liabilities and equity | 10,320 | 12,586 |
Spectral Diagnostics Inc. | |||||||||
Condensed Interim Statement of Loss and Comprehensive Loss | |||||||||
For the three months ended March 31, 2013 and 2012 | |||||||||
(Unaudited) | |||||||||
(in thousands of Canadian dollars, except for share and per share data) | |||||||||
2013 | 2012 | ||||||||
$ | $ | ||||||||
Revenue | 708 | 676 | |||||||
Other income | 5 | 36 | |||||||
Expenses | |||||||||
Changes in inventories of finished goods and work- in-process | 83 | 99 | |||||||
Raw materials and consumables used | 111 | 99 | |||||||
Employee benefits | 740 | 765 | |||||||
Consulting and professional fees | 1,304 | 1,190 | |||||||
Management services | 100 | 375 | |||||||
Regulatory and investor relations | 48 | 123 | |||||||
Travel and entertainment | 219 | 146 | |||||||
Depreciation and amortization | 55 | 51 | |||||||
Foreign exchange loss | 9 | 11 | |||||||
Other expenses | 138 | 117 | |||||||
2,807 | 2,976 | ||||||||
Operating loss | (2,094) | (2,264) | |||||||
Finance income | 17 | 16 | |||||||
Loss and comprehensive loss for the period | (2,077) | (2,248) | |||||||
Basic and diluted loss per common share | (0.02) | (0.02) | |||||||
Weighted average number of common shares outstanding | 113,883,394 | 113,883,394 |
Spectral Diagnostics Inc. | ||||||||||||||||||||
Condensed Interim Statement of Changes in Equity | ||||||||||||||||||||
(Unaudited) | ||||||||||||||||||||
(in thousands of Canadian dollars, except number of shares) | ||||||||||||||||||||
Issued capital | Contributed surplus | Share-based compensation | Warrants | Deficit | Total equity | |||||||||||||||
Number | $ | $ | $ | $ | $ | $ | ||||||||||||||
Balance, January 1, 2012 | 113,883,394 | 27,101 | 3,864 | 2,939 | 5,143 | (20,108) | 18,939 | |||||||||||||
Loss and comprehensive loss for the period | - | - | - | - | - | (2,248) | (2,248) | |||||||||||||
Share-based compensation | - | - | - | 92 | - | - | 92 | |||||||||||||
Balance, March 31, 2012 | 113,883,394 | 27,101 | 3,864 | 3,031 | 5,143 | (22,356) | 16,783 | |||||||||||||
Balance, January 1, 2013 | 113,883,394 | 27,101 | 3,864 | 3,117 | 5,143 | (28,651) | 10,574 | |||||||||||||
Loss and comprehensive loss for the period | - | - | - | - | - | (2,077) | (2,077) | |||||||||||||
Share-based compensation | - | - | - | 77 | - | - | 77 | |||||||||||||
Balance, March 31, 2013 | 113,883,394 | 27,101 | 3,864 | 3,194 | 5,143 | (30,728) | 8,574 |
Spectral Diagnostics Inc. | ||||||||||
Condensed Interim Statement of Cash Flows | ||||||||||
For the three months ended March 31, 2013 and 2012 | ||||||||||
(Unaudited) | ||||||||||
(in thousands of Canadian dollars) | ||||||||||
2013 | 2012 | |||||||||
$ | $ | |||||||||
Cash flow provided by (used in) | ||||||||||
Operating activities | ||||||||||
Loss and comprehensive loss for the period | (2,077) | (2,248) | ||||||||
Adjustments for: | ||||||||||
Depreciation on property, plant, and equipment | 48 | 45 | ||||||||
Amortization of intangible assets | 6 | 6 | ||||||||
Share-based compensation | 77 | 92 | ||||||||
Changes in items of working capital : | ||||||||||
Trade and other receivables | (83) | (266) | ||||||||
Inventories | (141) | 36 | ||||||||
Prepayments | (421) | (161) | ||||||||
Trade and other payables | (241) | 17 | ||||||||
Deferred revenue | (25) | (26) | ||||||||
Net cash used in operating activities | (2,857) | (2,505) | ||||||||
Investing activities | ||||||||||
Property, plant and equipment expenditures | (129) | (72) | ||||||||
Redemption of short-term investment | 5,137 | 5,086 | ||||||||
Purchase of short-term investment | (5,173) | (5,102) | ||||||||
Net cash used in investing activities | (165) | (88) | ||||||||
Decrease in cash and cash equivalents | (3,022) | (2,593) | ||||||||
Cash and cash equivalents, beginning of period | 5,425 | 13,470 | ||||||||
Cash and cash equivalents, end of period | 2,403 | 10,877 |
SOURCE: Spectral Diagnostics Inc.
For further information:Anthony Businskas
Executive Vice President and CFO
416-626-3233 ext. 2200
Adam Peeler
Investor Relations
TMX Equicom
416-815-0700 ext. 225
apeeler@tmxequicom.com
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