Spectral Diagnostics Inc., has announced its unaudited financial results for the third quarter ended September 30, 2013.
Third Quarter Highlights:
• Continued to enroll patients into the Company's Phase III EUPHRATES trial at an accelerated rate. Directed by the Company's Endotoxin Activity Assay (EAA™), which is the only FDA-cleared diagnostic for the risk of developing sepsis, Spectral's EUPHRATES trial, as currently configured, is targeted to enroll 306 evaluable patients in North America. At current enrollment rates, these patients would be enrolled by the end of the second quarter of 2014.
• Announced that the 184 patients required for the trial's planned, second interim analysis have been randomized. The 184 patients have now been followed for 28 days and all data is in the process of being gathered and analyzed. The Data and Safety Monitoring Board (DSMB) will review the data and the overall progress of the trial and advise Spectral on the trial's safety, futility and efficacy, with stopping rules in place for efficacy.
• Disclosed that the composite 28-day mortality rate of 33 percent for randomized patients in the trial continues to suggest that the trial is enrolling patients who are at greatest risk for a poor medical outcome and, therefore, would most likely benefit from the Company's theranostic treatment.
• As of November 12, 2013, 206 patients had been randomized into Spectral's EUPHRATES trial.
"We continued to enroll patients at an accelerated rate during the quarter." stated Dr. Paul Walker, President and CEO of Spectral. "We are very excited about learning the upcoming results of our data-rich, planned second interim analysis because we believe they should support the successful completion of the trial."
Spectral remains on track to disclose information from the second interim analysis in early 2014.
The second interim analysis will include, if needed, a sample size recalculation which will be based on the observed clinical trial data so far and will set a sample size that is required to attain a statistically and clinically significant difference in the mortality between the treated and placebo groups. This sample size recalculation, if needed, will also determine the expected timing for trial completion.
Revenue for the three months ended September 30, 2013 was $679,000, compared to $667,000 for the same period in the preceding year. For the nine months ended September 30, 2013 revenue was $1,959,000 compared to $1,942,000 for the same period in 2012.
Total expenses for the three months ended September 30, 2013 were $3,217,000 compared to $2,787,000 in the third quarter of 2012. For the nine months ended September 30, 2013 total expenses were $9,666,000 compared to $8,561,000 for the same prior-year period. This increase of $1,105,000 for the nine months ended September 30, 2013 is directly attributable to the higher EUPHRATES trial costs of $1,845,000 mitigated by a $648,000 decrease in management services fees and other operating costs.
The Company continues to maintain a low-cost operating structure and expects no material increase in non clinical operating costs for the remainder of 2013.
For the quarter ended September 30, 2013, the Company reported a loss of $2,517,000 compared to a loss of $2,077,000 for the corresponding period in 2012. For the nine months ended September 30, 2013, Spectral reported a loss of $7,634,000 compared to $6,476,000 for the same period in 2012. The Company's loss was greater for the three and nine months of 2013 primarily due to higher costs for its EUPHRATES trial.
Spectral concluded the third quarter of 2013 with cash, cash equivalents and short-term investment of $9,044,000 compared to $10,562,000 as at December 31, 2012. Subsequent to the quarter end, the Company received $585,000 cash on the exercise of 1,462,500 share purchase warrants at an exercise price of $0.40 per common share.
The total number of shares outstanding for the Company was 133,000,061 as at September 30, 2013.