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Spectral Announces First Quarter Results

TORONTO, May 11, 2018 (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 unaudited financial results for the first quarter ended March 31, 2018.

Financial Review

Revenue for the three months ended March 31, 2018 was $1,163,000 compared to $910,000 for the same three-month period last year. First quarter revenues were consistent with prior year levels.

Operating costs for the quarter ended March 31, 2018 were $1,877,000 compared to $1,903,000 for the same period in 2017.  Most of the Company’s expenses are incurred in its Phase III clinical trial and regulatory program and will vary depending on the timing and determination of the regulatory path forward. Apart from clinical trial and regulatory activities, the Company continues to maintain a low cost operating structure for its base business operations.

Loss for the quarter ended March 31, 2018 was $714,000 ($0.003 per share) compared to $993,000 ($0.005 per share) for the same quarter last year.

The Company concluded the first quarter of 2018 with cash on hand of $982,000 compared to $1,449,000 as of December 31, 2017. After closing of its private placement financing subsequent to the quarter end, the Company had $5,842,000 of cash to pursue its regulatory approval for the PMX cartridge, working capital, and general corporate purposes.

The total number of shares outstanding for the Company was 207,796,522 as at March 31, 2018.

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.

 

For further information, please contact:

Paul Walker
President and CEO
Spectral Medical Inc.
416-626-3233 ext. 2100
pwalker@spectraldx.com
Ali Mahdavi
Capital Markets & Investor Relations
416-962-3300
am@spinnakercmi.com


 
Spectral Medical Inc.
Condensed Interim Consolidated Statements of Financial Position
(Unaudited)
(in thousands of Canadian dollars)
      
 March 31 2018  December 31 2017  January 01 2017 
   Restated (Note 7)  Restated (Note 7) 
 $  $  $ 
      
Assets     
Current assets     
Cash982  1,449  5,080 
Trade and other receivables857  881  642 
Inventories298  191  244 
Prepayments and other assets249  73  166 
Contract asset126  -  - 
 2,512  2,594  6,132 
Non-current assets     
Property and equipment526  570  634 
Intangible asset303  309  334 
      
Total assets3,341  3,473  7,100 
      
Liabilities     
Current liabilities     
Trade and other payables514  612  1,112 
Contract liability3  3  6 
Total liabilities517  615  1,118 
      
Equity      
Share capital63,345  63,225  63,084 
Contributed surplus7,981  7,849  7,849 
Share-based compensation5,474  4,914  4,103 
Warrants-  132  132 
Deficit(73,976) (73,262) (69,186)
Total equity2,824  2,858  5,982 
      
Total liabilities and equity3,341  3,473  7,100 
         


 
Spectral Medical Inc.
Condensed Interim Consolidated Statements of Loss and Comprehensive Loss
For the three months ended March 31, 2018 and 2017
(Unaudited)
(in thousands of Canadian dollars, except for share and per share data)
      
 2018  2017 
   Restated (Note 7) 
 $   $ 
    
Revenue1,163  910 
    
Expenses   
Changes in inventories of finished goods and work- in-process24  15 
Raw materials and consumables used68  52 
Employee benefits1,165  1,080 
Consulting and professional fees210  320 
Product development-  50 
Regulatory and investor relations198  96 
Travel and entertainment28  86 
Depreciation and amortization62  54 
Foreign exchange (gain) loss(30) 3 
Other expenses152  147 
 1,877  1,903 
    
Loss and comprehensive loss for the period(714) (993)
    
Basic and diluted loss per common share(0.003) (0.005)
    
Weighted average number of common shares outstanding207,584,717  207,165,587 
      


           
Spectral Medical Inc.
Condensed Interim Consolidated Statements of Changes in Equity
For the three months ended March 31, 2018 and 2017
(Unaudited)
(in thousands of Canadian dollars)
           
 Issued capitalContributed surplusShare-based compensation Warrants Deficit Total equity 
 Number$$$ $ $ $ 
Balance, January 1, 2017207,165,58763,0847,8494,103 132 (69,346)5,822 
Change in accounting policies---- - 160 160 
Restated equity, January 1, 2017207,165,58763,0847,8494,103 132 (69,186)5,982 
Loss and comprehensive loss  for the period, restated---- - (993)(993)
Share-based compensation---310 - - 310 
Balance, March 31, 2017207,165,58763,0847,8494,413 132 (70,179)5,299 
Share options exercised293,435141-(57)- - 84 
Loss and comprehensive loss  for the period, restated---- - (3,083)(3,083)
Share-based compensation-- 558  - 558 
Balance, December 31, 2017207,459,02263,2257,8494,914 132 (73,262)2,858 
        
Balance, January 1, 2018207,459,02263,2257,8494,914 132 (73,285)2,835 
Change in accounting policies---- - 23 23 
Restated equity, January 1, 2018207,459,02263,2257,8494,914 132 (73,262)2,858 
Share options exercised337,500120-(49)- - 71 
Warrant expiry--132- (132)- - 
Loss and comprehensive loss for the period---- - (714)(714)
Share-based compensation---609 - - 609 
Balance, March 31, 2018207,796,52263,3457,9815,474 - (73,976)2,824 
            

 

 
Spectral Medical Inc.
Condensed Interim Consolidated Statements of Cash Flows
For the three months ended March 31, 2018 and 2017
(Unaudited)
(in thousands of Canadian dollars)
      
 2018  2017 
   Restated (Note 7) 
 $  $ 
Cash flow provided by (used in)   
    
Operating activities   
Loss and comprehensive loss for the period(714) (993)
Adjustments for:   
Depreciation on property and equipment56  48 
Amortization of intangible asset6  6 
Share-based compensation609  310 
Changes in items of working capital :   
Trade and other receivables24  (150)
Inventories  (107) (15)
Prepayments and other assets(176) (133)
Contract asset(126) - 
Trade and other payables(98) (354)
Contract liability-  (4)
Net cash used in operating activities(526) (1,285)
    
Investing activities   
Property and equipment expenditures(12) (81)
Net cash used in investing activities(12) (81)
    
Financing activities   
Share options exercised71  - 
Net cash provided by financing activities71  - 
    
Decrease in cash(467) (1,366)
    
Cash, beginning of period1,449  5,080 
Cash, end of period982  3,714 
Friday, May 11, 2018 - 08:00