Spectral Announces First Quarter Results

Spectral Announces First Quarter Results

TORONTO, ONTARIO--(Marketwired - May 12, 2016) - Spectral Medical Inc., (TSX:EDT) (OTCQX:EDTXF), 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, 2016.

Financial Review

Revenue for the three months ended March 31, 2016 was $1,062,000 compared to $877,000 for the same three month period last year. First quarter revenues 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 March 31, 2016 were $4,069,000 compared to $3,223,000 in 2015. Most of the Company's expenses are incurred in its Phase III clinical trial and will 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.

Loss for the quarter ended March 31, 2016 was $2,994,000 ($0.02 per share) compared to $2,322,000 ($0.01 per share) for the same quarter last year.

The Company concluded the first quarter of 2016 with cash on hand of $12,861,000 compared to $6,369,000 as of December 31, 2015.

In February, 2016, the Company closed a bought deal prospectus financing for net proceeds of $9,042,000.

The total number of shares outstanding for the Company was 206,733,209 as at March 31, 2016.

Corporate Update

The clinical trial is on track to complete enrollment by the end of June, 2016. There will be a corporate update on clinical and regulatory activities to be released prior to the Annual General Meeting.

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. 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 in the area of septic shock.

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, 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.

Spectral Medical Inc.

Condensed Interim Consolidated Statements of Financial Position

(Unaudited)

(in thousands of Canadian dollars)  
   
  March 31   December 31  
  2016   2015  
  $   $  
   
Assets        
Current assets        
Cash 12,861   6,369  
Trade and other receivables 886   630  
Inventories 325   243  
Prepayments and other assets 301   141  
  14,373   7,383  
Non-current assets        
Property and equipment 735   717  
Intangible asset 353   359  
  1,088   1,076  
   
Total assets 15,461   8,459  
   
Liabilities        
Current liabilities        
Trade and other payables 2,828   2,850  
Deferred revenue 167   176  
Total liabilities 2,995   3,026  
   
Equity        
Share capital 62,918   53,058  
Contributed surplus 7,849   7,849  
Other equity reserves 3,890   3,723  
Deficit (62,191 ) (59,197 )
Total equity 12,466   5,433  
   
Total liabilities and equity 15,461   8,459  

Spectral Medical Inc.

Condensed Interim Consolidated Statements of Loss and Comprehensive Loss

For the three months ended March 31, 2016 and 2015

(Unaudited)

(in thousands of Canadian dollars, except for share and per share data)

  2016   2015  
  $   $  
Revenue 1,062   877  
Expenses        
Changes in inventories of finished goods and work-in-process 25   24  
Raw materials and consumables used 203   100  
Employee benefits 1,241   1,004  
Consulting and professional fees 2,055   1,572  
Product development        
Regulatory and investor relations 135   170  
Travel and entertainment 209   203  
Depreciation and amortization 42   43  
Foreign exchange loss (gain) 15   (17 )
Other expenses 144   124  
  4,069   3,223  
   
Operating loss (3,007 ) (2,346 )
Finance income 13   24  
   
Loss and comprehensive loss for the period (2,994 ) (2,322 )
   
Basic and diluted loss per common share (0.02 ) (0.01 )
   
Weighted average number of common shares outstanding 198,015,803   179,750,247  

Spectral Medical Inc.

Condensed Interim Consolidated Statements of Changes in Equity

For the three months ended March 31, 2016 and 2015

(Unaudited)

(in thousands of Canadian dollars)

 
 
 Issued capital  
 
Contributed
surplus
 
 
Share-based
compensation
 
 
 
 
Warrants  
 
Deficit  
 
Total equity  
 
  Number   $   $   $     $   $   $  
Balance, January 1, 2015 179,737,241   46,879   7,849   3,542     -   (49,450 ) 8,820  
Shares repurchased under NCIB (90,000 ) (23 )               (32 ) (55 )
Share options exercised 108,500   84   -   (41 )   -   -   43  
Loss and comprehensive loss for the period -   -   -   -     -   (2,322 ) (2,322 )
Share-based compensation -   -   -   162     -   -   162  
Balance, March 31, 2015 179,755,741   46,940   7,849   3,663     -   (51,804 ) 6,648  
   
Balance, January 1, 2016 190,771,405   53,058   7,849   3,723     -   (59,197 ) 5,433  
Bought deal prospectus offering 15,106,804   9,402   -   -     -   -   9,402  
Share options exercised 855,000   458   -   (192 )   -   -   266  
Loss and comprehensive loss for the period -   -   -   -     -   (2,994 ) (2,994 )
Share-based compensation -   -   -   359     -   -   359  
Balance, March 31, 2016 206,733,209   62,918   7,849   3,890     -   (62,191 ) 12,466  

Spectral Medical Inc.

Condensed Interim Consolidated Statements of Cash Flows

For the three months ended March 31, 2016 and 2015

(Unaudited)

(in thousands of Canadian dollars)        
  2016   2015  
  $   $  
Cash flow provided by (used in)        
Operating activities        
Loss and comprehensive loss for the period (2,994 ) (2,322 )
Adjustments for:        
  Depreciation on property and equipment 35   37  
  Amortization of intangible asset 6   6  
  Share-based compensation 359   162  
Changes in items of working capital :        
  Trade and other receivables (256 ) (92 )
  Inventories (82 ) (52 )
  Prepayments and other assets (160 ) (49 )
  Trade and other payables (22 ) (482 )
  Deferred revenue (9 ) (64 )
Net cash used in operating activities (3,123 ) (2,856 )
Investing activities        
Property and equipment expenditures (53 ) (118 )
Net cash used in investing activities (53 ) (118 )
Financing activities        
Bought deal prospectus offering 9,402   -  
Share options exercised 266   43  
Shares repurchased under NCIB -   (55 )
Net cash provided by (used in) financing activities 9,668   (12 )
Increase(decrease) in cash 6,492   (2,986 )
Cash, beginning of period 6,369   10,054  
Cash, end of period 12,861   7,068  

Anthony Businskas
Executive Vice President and CFO
Spectral Medical Inc.
416-626-3233 ext. 2200
[email protected]

Ali Mahdavi
Capital Markets & Investor Relations
416-962-3300
[email protected]