Spectral Diagnostics Inc., has announced its financial results for the second quarter ended June 30, 2012.
Second Quarter Highlights:
• Announced that the United States Food and Drug Administration (FDA) will allow Spectral to double the number of trial sites to sixty in total, for the Company's personalized medicine approach to treating septic shock;
• Continued enrolling patients into the Company's Phase III EUPHRATES trial at a per site rate that is higher than previous sepsis trials. 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 is currently targeted to enroll 306 evaluable patients at up to 60 sites in North America and internationally. Sixty two patients have been randomized into the trial as of July 31, 2012.
• Disclosed that the Company's focused approach to patient selection, using a high endotoxin level as entry criteria, has resulted in a composite mortality rate ranging from 35% to 40% in its Phase III trial, compared to a predicted composite mortality of 27.5%. This is positive news, as a challenge faced by recent, unsuccessful sepsis trials has been the low rate of placebo mortality, which may make demonstration of benefit difficult;
• Concluded the reporting period with approximately $14.3 million in cash and short term investments.
"We are very excited about the progress we are making with the EUPHRATES trial," said Dr. Paul Walker, President and CEO of Spectral Diagnostics.
Dr. Walker continued, "As the enrollment of patients in our Phase III trial progresses, we are increasing our lead to potentially introduce a new sepsis product to a market with a very large unmet medical need."
Revenue for the three months ended June 30, 2012 was $599,000 compared to $691,000 for the same period in the preceding year. For the six months ended June 30, 2012 revenue was $1,275,000 compared to $1,313,000 for the same period in 2011.
For the second quarter ended June 30, 2012, the Company reported a loss of $2,151,000 compared to a loss of $1,717,000 for the corresponding period in 2011.
For the six months ended June 30, 2012, Spectral reported a loss of $4,399,000 compared to $3,175,000 for the same period in 2011.
The Company's loss was greater for the three and six months of 2012 due to higher costs for its Phase III EUPHRATES trial.
Cash, cash equivalents and short-term investments on hand at June 30, 2012 were $14.3 million.
Cash was used during the quarter ended June 30, 2012 to fund operations and for working capital purposes.
The total number of shares outstanding for the Company was 113,883,394 as at June 30, 2012.