Spectral Diagnostics Inc., has announced its financial results for the third quarter ended September 30, 2012.
Third Quarter Highlights:
• Announced that the U.S. Food and Drug Administration approved an amended protocol for Spectral's Phase III EUPHRATES trial, which will now have two planned interim analyses instead of one. Spectral requested the amendment, including the strategy for two interim analyses.
The first interim analysis, for safety, will occur when 76 randomized patients have been followed for 28 days. Seventy three patients have been randomized into the trial at 25 sites as of October 31, 2012.
The second interim analysis - anticipated in the first half of 2014 - will occur after 184 randomized patients have been followed for 28 days. At the second analysis, the Data Safety Monitoring Board will advise Spectral on the trial's safety and efficacy. Stopping rules for efficacy are included in the second interim analysis.
• 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.
Contingent on maintaining current enrolment rates and timely site start ups, the trial should be fully enrolled by the end of 2014.
• Announced an exclusive distribution agreement with Toray International Italy S.r.l. - a subsidiary of Toray Industries, Inc. - to sell the Company's Endotoxin Activity Assay in combination with Toraymyxin in Saudi Arabia and Turkey.
The expansion of commercial jurisdictions with Toray further confirms the outstanding market opportunity for the Company's unique theranostic treatment for septic shock.
• Concluded the reporting period with approximately $12.2 million in cash, cash equivalents and short- term investments.
"As the enrollment of patients in our Phase III trial progresses, we are closing in on a number of inflection points for our current and prospective investors," said Dr. Paul Walker, President and CEO of Spectral Diagnostics.
Dr. Walker continued, "In addition, there continues to be a significant unmet medical need in the area of severe sepsis, and we feel we are at the forefront of meeting that need with our theranostic treatment."
Revenue for the three months ended September 30, 2012 was $667,000 compared to $489,000 for the same period in the preceding year. For the nine months ended September 30, 2012 revenue was $1,942,000 compared to $1,802,000 for the same period in 2011.
For the second quarter ended September 30, 2012, the Company reported a loss of $2,077,000 compared to a loss of $1,632,000 for the corresponding period in 2011.
For the nine months ended September 30, 2012, Spectral reported a loss of $6,476,000 compared to $4,807,000 for the same period in 2011. The Company's loss was greater for the three and nine months of 2012 due to higher costs for its Phase III EUPHRATES trial.
Cash, cash equivalents and short-term investments on hand at September 30, 2012 were $12.2 million. Cash was used during the quarter ended September 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 September 30, 2012.