Spectral Diagnostics Inc., has announced its audited financial results for the fourth quarter and year ended December 31, 2013.
Fourth Quarter Highlights:
• Continued to enroll patients into the Company's Phase III EUPHRATES trial. As of March 26, 2014, 265 patients have been randomized into the study.
• On January 27, 2014 announced that the Data Safety Monitoring Board (DSMB) had evaluated the safety, efficacy and futility of its EUPHRATES trial based on actual data for 184 randomized patients followed for 28 days. The DSMB recommended that the trial continue, but asked that further analysis be performed before recalculation of the trial's sample size is finalized.
• Subsequent to year end, on February 20, 2014, the Company extended the expiry date of its $0.60 warrants from March 2, 2014 to September 2, 2014, subject to obtaining all regulatory and shareholder approvals.
• On March 11, 2014, the Company disclosed that it has scheduled the next quarterly DSMB meeting in early April, 2014 at which time it anticipates receiving the recommendations of the DSMB based on its review of the requested detailed analysis, as well as data from additional patients enrolled since the 184 patient cut off for the second interim analysis. The Company expects to announce its clinical path forward after receiving and evaluating the DSMB recommendations.
"The progress that we made in 2013 with the EUPHRATES trial has put us in a good position to better understand the path forward for our Phase III sepsis product," stated Dr. Paul Walker, President and CEO of Spectral. "We look forward to sharing that disclosure with the market in the coming weeks."
Revenue for the three months ended December 31, 2013 was $713,000 compared to $647,000 for the same three month period last year. Revenue for the year ended December 31, 2013 was $2,672,000 compared to $2,589,000 for the prior year, representing an increase of $83,000.
For the quarter ended December 31, 2013, the Company reported operating costs of $4,396,000 compared to $2,752,000 for the corresponding period in 2012. Operating costs for the year ended December 31, 2013 amounted to $14,062,000 compared to $11,313,000 in 2012. The $2,749,000 increase in operating costs is almost entirely attributable to increased EUPHRATES trial activities. During the year, 19 clinical sites were added and 142 patients were enrolled into the study. Apart from clinical trial activities, the Company continues to maintain a low cost operating structure for its base business operations.
Loss for the quarter ended December 31, 2013 was $3,673,000 ($0.03 per share) compared to $2,067,000 ($0.02 per share) for the same quarter last year. For the year ended December 31, 2013, the Company reported a loss of $11,307,000, ($0.09 per share), compared to a loss of $8,543,000 ($0.08 per share), for the year ended December 31, 2012.
The Company concluded the 2013 year with cash and cash equivalents of $7,229,000 compared to $10,562,000 cash and cash equivalents on hand as of December 31, 2012.
The total number of shares outstanding for the Company was 134,462,561 as at December 31, 2013.