Spectral announces first quarter, 2014 results

TORONTO, May 15, 2014 /CNW/ - Spectral Diagnostics Inc., (TSX:SDI) (OTCQX: DIAGF), a Phase III company developing the first theranostic treatment for patients with severe sepis and septic shock, today announced its unaudited financial results for the first quarter ended March 31, 2014.

First Quarter Highlights:

• Continued to enroll patients into the Company's Phase III EUPHRATES trial. As of May 14, 2014, 275 patients have been randomized into the study.
  
  
• On February 20, 2014, the Company extended the expiry date of its $0.60 warrants from March 2, 2014 to September 2, 2014. Shareholders approved the extension at the Company's Annual and Special meeting held on May 5, 2014.
  
  
• Subsequent to quarter end, on April 14, 2014, the Company announced that the Data Safety Monitoring Board (DSMB) for the EUPHRATES trial completed its review of the detailed analysis it had previously requested. Based on the current recommendations of the DSMB, the trial's sample size has been recalculated and increased from 360 to 650 patients. This increase in the number of enrolled patients enhances the likelihood of demonstrating, with sufficient power, a statistically and clinically significant effect. The revised sample size falls within the statistical plan already agreed to by the United States Food and Drug Administration (FDA). Spectral has submitted a protocol amendment to the FDA, as recommended by the DSMB, for an additional exclusion criterion.
  
  
• On May 6, 2014, the Company announced that shareholders approved a name change to "Spectral Medical Inc." that will take effect at a future date to be determined by Spectral's Board of Directors.

Financial Review

Revenue for the three months ended March 31, 2014 was $844,000 compared to $708,000 for the same period in the preceding year. The $136,000 increase is attributable primarily to the timing of orders under existing distribution agreements. Revenue levels in 2014 are expected to be consistent with those achieved in 2013.

For the three months ended March 31, 2014, the Company reported a loss of $3,175,000 ($0.02 per share) compared to a loss of $2,077,000 ($0.02 per share) for the three months ended March 31, 2013. The increase in the loss is due primarily to costs resulting from higher patient  enrolment in the EUPHRATES trial  in 2014 compared to the same quarter last year and  certain related corporate initiatives.

The Company concluded the first quarter of 2014 year with cash and cash equivalents of $3,730,000 compared to $7,229,000 cash and cash equivalents on hand as of December 31, 2013. The Company expects to raise additional capital to fund its operations and anticipates that a financing should be completed in the third quarter of this year.

The total number of shares outstanding for the Company was 134,462,607 as at March 31, 2014.

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. PMX 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 only active and most innovative Phase III study in the area of septic shock.

PMX 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 PMX, and in November 2010, signed an exclusive distribution agreement for this product in Canada. Approximately 350,000 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 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.

SOURCE Spectral Diagnostics Inc.