Spectral Medical Inc.

Spectral Medical Inc.

November 13, 2015 08:00 ET

Spectral Announces Third Quarter 2015 Results

TORONTO, ONTARIO--(Marketwired - Nov. 13, 2015) - Spectral Medical Inc., (TSX:EDT)(OTCQX:EDTXF), a Phase III company developing the first treatment for patients with septic shock that comprises a therapeutic device guided by a companion diagnostic, today announced its unaudited financial results for the third quarter ended September 30, 2015.

Financial Review

Revenue for the three months ended September 30, 2015 was $679,000 compared to $643,000 for the same period in the preceding year. For the nine months ended September 30, 2015 revenues were $2,374,000 compared to $2,265,000 in the first nine months of 2014. Revenues for both the quarter and the year were consistent with prior year levels and this trend is expected to continue for the remainder of the year.

Operating costs for the quarter ended September 30, 2015 amounted to $3,192,000 compared to $2,668,000 in 2014. Operating costs for the nine months ended were $9,566,000, representing a decrease of $364,000 from $9,930,000 for the first nine months of 2014. The year to date decrease is almost entirely attributable to lower costs for the EUPHRATES trial, resulting from fewer new sites being initiated into the trial and lower patient enrolment after the implementation of an additional exclusion criterion in April, 2014 that refined patient selection. The higher costs in the third quarter of 2015 were related to expenses incurred for the PMA submission and investigator meetings. Apart from clinical trial activities, the Company continues to maintain a low cost operating structure for its base business operations.

For the three months ended September 30, 2015, the Company reported a loss of $2,493,000 ($0.01 per share) compared to a loss of $ $1,403,000 ($0.01 per share) for the three months ended September 30, 2014. The loss for the nine months ended September 30, 2015 was $7,124,000 ($0.04 per share) compared to $7,029,000 ($0.05 per share) for the same nine month period in the prior year.

The Company concluded the third quarter of 2015 with cash and cash equivalents of $8,404,000 compared to $10,054,000 cash and cash equivalents on hand as of December 31, 2014.

The total number of shares outstanding for the Company was 190,686,405 as at September 30, 2015.

About Spectral

Spectral is a Phase III company seeking U.S. FDA approval for its lead theranostics product for the treatment of endotoxemic septic shock. Toraymyxin ™ (PMX) is a therapeutic hemoperfusion device that removes endotoxin, a main trigger of sepsis, from the bloodstream. Directed by the Company's Endotoxin Activity Assay (EAA™), the only FDA cleared diagnostic for the risk of developing sepsis, Spectral's EUPHRATES trial is the world's only active and most innovative Phase III study for a medical device in the area of septic shock.

PMX has been approved for therapeutic use in Japan and Europe, and has been used on more than 150,000 patients to date. In March 2009, Spectral obtained the exclusive development and commercial rights in the U.S. for PMX, and in November 2010, signed an exclusive distribution agreement for this product in Canada. Approximately 350,000 patients are diagnosed with septic shock in North America each year, representing a greater than $3 billion market opportunity for Spectral.

Spectral is listed on the Toronto Stock Exchange under the symbol EDT, and on the OTCQX under the symbol EDTXF. For more information please visit www.spectraldx.com.

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.

The TSX has not reviewed and does not accept responsibility for the adequacy or accuracy of this statement.

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