Spectral announces fourth quarter and 2011 results

TORONTO, March 16, 2012 /CNW/ - Spectral Diagnostics Inc., (TSX: SDI), a Phase III company developing the first theranostic treatment for patients with severe sepsis and septic shock, today 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. "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.

About Spectral Diagnostics

Spectral is a Phase III company seeking U.S. FDA approval for its lead theranostics product for the treatment of 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, where it is approved for sale by Health 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 more 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.

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