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Spectral Announces Fourth Quarter and 2011 Results

Published: Monday, March 19, 2012
Last Updated: Monday, March 19, 2012
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Company is expanding its U.S. Phase III EUPHRATES trial to Canadian clinical trial sites.

Spectral Diagnostics Inc., has announced its financial results for the fourth quarter and year ended December 31, 2011.

Fourth Quarter Highlights:
• Continued to enroll patients into the Company's Phase III EUPHRATES trial. 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. The trial is targeted to enroll approximately 360 patients at 30 U.S. and Canadian sites;
• Concluded the reporting period with approximately $18.5 million in cash and short term investments;
• Announced the Company is expanding its U.S. Phase III EUPHRATES trial to Canadian clinical trial sites;
• Subsequent to quarter end, announced that its common shares began trading on OTCQX International, the highest tier of the OTC market in the United States, under the symbol "DIAGF".

Spectral expects to benefit from trading on OTCQX by gaining greater exposure and liquidity in the United States, which represents the major market for its theranostic treatment, and where most of its Phase III EUPHRATES trial sites are located.

"Our EUPHRATES trial remains the most advanced in the area of severe sepsis and is the only currently active Phase III trial. In the past six months, a commercial sepsis product was pulled from the market, and a late stage clinical trial for another product was halted due to safety concerns ", said Dr. Paul Walker, President and CEO of Spectral Diagnostics.

Dr. Walker continued, "For Spectral, these events reinforce two things. First, there continues to be a large unmet medical need in the area of septic shock. Second, as we continue to enroll patients in our Phase III sepsis trial, we are closer to potentially introducing an exciting new product for severe sepsis and septic shock to the market."

Financial Review
Revenues for the three months ended December 31, 2011 were $628,000 compared to $712,000 for the same period in 2010. For the year ended December 31, 2011, revenues were $2,430,000 compared to $2,981,000 for 2010.

Revenues declined from 2010 levels due mainly to the timing and revised terms of certain EAA™ distribution agreements that were renegotiated subsequent to their expiry in the previous year.

Also, revenues are predominantly denominated in U.S. and EURO currencies and have been impacted by the continuing strength of the Canadian dollar.

For the three months ended December 31, 2011, the Company reported a loss of $1,940,000 compared to $2,010,000 for the corresponding period in 2010. For the year ended December 31, 2011, the Company reported a loss of $6,713,000, or ($0.07) per share, compared to a loss of $6,498,000 or ($0.10) per share for the corresponding period in 2010.

Cash, cash equivalents and short-term investments on hand at December 31, 2011 were $18,556,000 compared to $15,332,000 at December 31, 2010.

Cash was used during the quarter and year ended December 31, 2011 to fund operations and for working capital purposes.

The total number of shares outstanding for the Company was 113,883,394 as at December 31, 2011.

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