Spectral Announces Second Quarter Results

TORONTO, ONTARIO--(Marketwired - Aug. 11, 2017) - Spectral Medical Inc., (TSX:EDT), a Phase III company developing the first treatment for patients with septic shock, today announced its unaudited financial results for the second quarter ended June 30, 2017.

Financial Review

Revenue for the three months ended June 30, 2017 was $1,090,000 compared to $870,000 for the same period in the preceding year. For the six months ended June 30, 2017 revenues were $2,031,000 compared to $1,932,000 in the first half of 2016. 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 June 30, 2017 amounted to $2,205,000 compared to $4,393,000 in 2016. Operating costs for the six months ended were $4,108,000, a decrease of $4,354,000 from $8,462,000 for the first six months of 2016. The decrease is almost entirely attributable to lower costs for the EUPHRATES trial. The fourth and final module of the PMA submission was provided to the U.S. FDA in the second quarter of 2017 and accepted for substantive review on July 20, 2017. The Company continues to maintain a low cost operating structure for its base business operations.

For the three months ended June 30, 2017, the Company reported a loss of $1,115,000 ($0.005 per share) compared to a loss of $3,498,000 ($0.02 per share) for the three months ended June 30, 2016. The loss for the six months ended June 30, 2017 was $2,077,000 ($0.01 per share) compared to $6,492,000 ($0.03 per share) for the same six month period in the prior year.

The Company concluded the second quarter of 2017 with cash on hand of $2,912,000 compared to $5,080,000 as of December 31, 2016.

The total number of shares outstanding for the Company was 207,440,587 as at June 30, 2017.

About Spectral

Spectral is a Phase III company seeking U.S. FDA approval for its unique product for the treatment of patients with septic shock, Toraymyxin™ ('PMX"). PMX is a therapeutic hemoperfusion device that removes endotoxin, which can cause sepsis, from the bloodstream.

PMX has been approved for therapeutic use in Japan and Europe, and has been used safely and effectively 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 severe sepsis and septic shock in North America each year. Spectral is listed on the Toronto Stock Exchange under the symbol EDT. 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.