TORONTO, May 14 /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 first quarter ended March 31, 2009.
"This quarter, we achieved an important milestone by securing the exclusive rights to develop and commercialize Toraymyxin(TM) for the US market after thorough due diligence into the product and its potential market opportunity," said Dr. Paul Walker, President and CEO of Spectral. "Toraymyxin(TM) has been used on more than 70,000 patients to date, primarily in Europe and Japan, for the treatment of severe sepsis and has demonstrated a significant reduction in the mortality of patients with severe sepsis compared to standard of care. We believe that, when used together with our proprietary Endotoxin Activity Assay (EAA(TM)), Toraymyxin(TM) represents a significant medical advance in helping doctors manage a devastating disease. Our next steps will be to obtain an Investigational Device Exemption (IDE) from the US FDA and to initiate a registration trial for Toraymyxin(TM) in 2009."
Financial Review
For the three months ended March 31, 2009, Spectral reported sales of $842,000, compared to $664,000 for the corresponding period in 2008. This represents a 27% increase. Sales in all product categories were higher due to improved EAA(TM) diagnostic sales and the consistency of royalty revenues and reagent sales related to the Company's proprietary Troponin I products.
Operating expenses for the three months ended March 31, 2009 were $1,043,000, compared to $976,000 for the corresponding period in 2009, due to the continued maintenance of a low cost operating structure. These expenses included $100,000 of costs related to the development of the Toraymyxin(TM) clinical pathway.
For the three months ended March 31, 2009, the Company reported a loss of $404,000, or ($0.02) per share, compared to a loss of $448,000 or ($0.02) per share for the corresponding period in 2008.
Cash and short term investments as at March 31, 2009 totaled $4,053,000, compared to $4,297,000 as at December 31, 2008. Management expects that the Company will maintain a minimum cash and short term investment balance of $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.
CONTACT: Dr. Paul Walker, President & CEO, (416) 626-3233 ex. 2100; Casey
Gurfinkel, Investor Relations, (416) 815-0700 ext. 283,
cgurfinkel@equicomgroup.com
