Spectral Announces Fourth Quarter and Fiscal 2018 Results

TORONTO, March 28, 2019 (GLOBE NEWSWIRE) -- Spectral Medical Inc., (TSX: EDT), a Phase III company developing the first treatment for patients with septic shock guided by a companion diagnostic, today announced its financial results for the fourth quarter and for the year ended December 31, 2018.

Financial Review

Revenue for the three months ended December 31, 2018 was $1,864,000 compared to $884,000 for the same three-month period last year. Revenue for the year ended December 31, 2018 was $3,840,000 compared to $3,669,000 for the prior year, representing an increase of $171,000, or 5%.

For the quarter ended December 31, 2018, the Company reported operating costs of $1,420,000 compared to $1,960,000 for the corresponding period in 2017. Operating costs for the year ended December 31, 2018 amounted to $6,329,000 compared to $7,745,000 in 2017. Most of the Company’s expenses are incurred in its Phase III clinical trial and vary depending on the timing and level of patient enrolment. Apart from clinical trial activities, the Company continues to maintain a low cost operating structure for its base business operations.

Income for the quarter ended December 31, 2018 was $444,000 ($0.002 per share) compared to a loss of $1,076,000 ($0.005 per share) for the same quarter last year. For the year ended December 31, 2018, the Company reported a loss of $2,489,000, ($0.01 per share), compared to a loss of $4,076,000 ($0.02 per share), for the year ended December 31, 2017.

The Company concluded the 2018 year with cash of $4,368,000 compared to $1,449,000 cash on hand as of December 31, 2017.

The total number of common shares outstanding for the Company was 225,591,183 as at December 31, 2018.

Corporate update

• Tigris protocol approved by the U.S. Food and Drug Administration and the study is to commence in the first half of 2019.
• The first order of Spectral continuous renal replacement therapy (“CRRT”) machines (“SAMI”) was received and delivered in the first quarter of 2019.
• Enhancement of Spectral’s renal replacement therapy program to include home hemodialysis.

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 and is guided by the Company’s Endotoxin Activity Assay (EAA™), the only FDA cleared diagnostic for the risk of developing sepsis.

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.

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Consolidated Statements of Financial Position

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Consolidated Statements of Loss and Comprehensive Loss
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Consolidated Statements of Changes in Equity
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Spectral Medical Inc.
Consolidated Statements of Cash Flows
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