Spectral Diagnostics Announces Second Quarter 2009 Results
TORONTO, Aug. 13 /PRNewswire-FirstCall/ - Spectral Diagnostics Inc., , a company focused on bringing to market a diagnostic and a therapeutic targeting severe sepsis, today announced its financial results for the second quarter ended June 30, 2009.
"During the quarter, results of the EUPHAS trial in Italy were published in the Journal of American Medical Association (JAMA). The findings showed that the Toraymyxin(TM) cartridge significantly reduced mortality from sepsis in a prospective controlled trial, further supporting our planned U.S. registration trial for this product," said Dr. Paul Walker, President and CEO of Spectral. "The degree of reduction in mortality demonstrated by Toraymyxin(TM) in the EUPHAS trial is an unprecedented result for sepsis therapies. We believe that Toraymyxin(TM), when used together with our proprietary Endotoxin Activity Assay (EAA(TM)), has the potential to fulfill an unmet need for the approximately 125,000 patients that develop severe sepsis or septic shock in the U.S. each year. Our work towards obtaining an Investigational Device Exemption (IDE) from the U.S. FDA is on schedule and we should be in a position to initiate our registration trial for Toraymyxin(TM) following IDE approval."
Financial Review
For the second quarter ended June 30, 2009, Spectral reported revenues of $776,000, compared to $785,000 for the corresponding period in 2008. For the six months ended June 30, 2009, revenues were $1,618,000 compared to $1,449,000 for the same 2008 period. Sales of the EAA(TM) diagnostic increased, while royalty and reagent revenues from the Company's proprietary Troponin I products remained consistent with prior year levels.
Operating expenses for the second quarter ended June 30, 2009 were $1,186,000, compared to $978,000 for the corresponding period in 2008. For the six months ended June 30, 2009, operating expenses were $2,229,000 compared to $1,954,000 in the same 2008 period. The increase in operating expenses in the first half of the year was entirely due to incremental consulting costs related to the development of the clinical pathway for Toraymyxin(TM) and the foreign exchange impact of a rising Canadian dollar against the U.S. currency. Operating expenses related to the existing business remained consistent with prior year levels.
For the second quarter ended June 30, 2009, the Company reported a loss of $701,000 or ($0.03) per share, compared to a loss of $419,000 or ($0.02) per share for the corresponding period in 2008. The second quarter loss included the above-mentioned consulting costs and foreign exchange loss, totaling $248,000, and an unrealized loss on the Company's bond portfolio ($91,000). For the six months ended June 30, 2009, the Company reported a loss of $1,105,000 or ($0.05) per share, compared to a loss of $867,000 or ($0.04) per share for the corresponding period in 2008.
Cash and short term investments as at June 30, 2009 totaled $3,436,000, compared to $4,297,000 as at December 31, 2008. Management expects that the Company will maintain a cash and short term investment balance of approximately $3,000,000 for the rest of 2009.
About Spectral Diagnostics
Spectral is a leader in the battle against sepsis. Spectral's lead product is its Endotoxin Activity Assay (EAA(TM)), the only FDA cleared assay for the measurement of endotoxin. With the growing awareness for the role of endotoxemia in sepsis and the increasing number of therapies being developed to treat endotoxemia, Spectral is well-positioned to promote the adoption of the EAA(TM), which can be used to identify patients, enable therapeutics and monitor treatment. Spectral is listed on TSX under the symbol SDI.
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.
SOURCE Spectral Diagnostics Inc.
CONTACT: Dr. Paul Walker, President CEO, (416) 626-3233 ex. 2100; Casey
Gurfinkel, Investor Relations, (416) 815-0700 ext. 283,
cgurfinkel@equicomgroup.com