SPECTRAL DIAGNOSTICS REFILES THIRD QUARTER UNAUDITED INTERIM FINANCIAL STATEMENTS

TORONTO, April 11 /CNW/ - Spectral Diagnostics Inc., (TSX: SDI), a Phase III company developing the first theranostic treatment for severe sepsis and septic shock, today announced that it has refiled, on SEDAR, its unaudited interim financial statements for the nine month period ended September 30, 2010 to include specific disclosure that these interim financial statements have not been subject to a review by the Company's auditors. Other than this disclosure, there are no changes to these unaudited interim financial statements.

About Spectral Diagnostics
Spectral is a Phase III company seeking U.S. FDA approval for its lead theranostics product for the treatment for severe sepsis and septic shock. Toraymyxin 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 first theranostics trial in the area of sepsis.

Toraymyxin has been approved for therapeutic use in 18 countries, and has been used safely and effectively in more than 80,000 patients to date. In March, 2009, Spectral obtained the exclusive development and commercial rights in the U.S. for Toraymyxin, and in November, 2010, signed an exclusive distribution agreement for this product in Canada. More than 250,000 patients are diagnosed with severe sepsis and septic shock in North America each year, representing a greater than $1 billion market opportunity for Spectral. Spectral is listed on the Toronto Stock Exchange under the symbol SDI.

For further 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 Diagnostics Inc.
Balance Sheets - unaudited
As at September 30, 2010 and December 31, 2009
_________________________________________________________________________
(in thousands of dollars)


                        2010
$
          2009
$
                                     
Assets                                    
                                     
Current assets
Cash and cash equivalents
Accounts receivable
Inventories
Prepaid expenses








































 
 
 
 
 
 
16,353
766
251
85
         
 
 
 
 
 
2,944
781
123
45
                                     
                        17,455           3,893
                                     
Property, plant and equipment                       406           457
                                     
Commercial instruments                       74           94
                                     
Purchased technology and trademarks                       736           588
                                     
                        18,671           5,032
                                     
Liabilities                                    
                                     
Current liabilities
Accounts payable and accrued liabilities
Current portion of convertible notes payable




















 
 
 
 
784
1,319
         
 
 
 
1,077
2,336
                        2,103           3,413
                                     
Deferred revenue                       157           254
                                     
                                     
                        2,260           3,667
                                     
Shareholders' Equity                                    
                                     
Common shares                       21,281           2,524
                                     
Other equity                       6,586           5,794
                                     
Deficit                       (11,456)           (6,953)
                                     
                        16,411           1,365
                                     
                        18,671           5,032
                                     

These unaudited interim financial statements have been prepared by management of Spectral Diagnostics Inc. and have not been reviewed by the Company's auditors.

Spectral Diagnostics Inc.
Statements of Operations, Comprehensive Loss and Deficit - unaudited
For the nine months ended September 30, 2010 and 2009
_________________________________________________________________________________________________________
(in thousands of dollars, except share and per share data)

      3 Months Ended
September 30
  9 Months Ended
September 30
               
      2010
$
2009
$
  2010
$
2009
$
               
Sales     722 815   2,148 2,433
               
Cost of sales     138 232   457 582
               
Gross margin     584 583   1,691 1,851
               
Operating expenses
Selling, general and administrative
Clinical trial
Service fees
Amortization
Foreign exchange loss
Stock-based compensation
Research and product development, net of tax credits
     
850
595
250
155
35
-
-
 
707
41
-
155
59
32
5
 
 
 
 
 
 
 
 
 
2,511
1,563
750
466
48
792
24
 
2,261
305
-
478
111
32
41
               
      1,885 999   6,154 3,228
               
Loss before the following     (1,301) (416)   (4,463) (1,377)
               
Interest on convertible notes payable     (24) (41)   (83) (123)
               
Other net investment income (loss)     35 28   43 (34)
               
               
Loss and comprehensive loss for the period     (1,290) (429)   (4,503) (1,534)
               
Deficit - Beginning of period     (10,166) (5,294)   (6,953) (4,189)
               
Deficit - End of period     (11,456) (5,723)   (11,456) (5,723)
               
Basic and diluted loss per common share                    (0.02)                (0.01)                  (0.07)                (0.06)
               
Weighted average number of common
shares outstanding
    75,844,484 24,118,424   64,281,721 24,118,424

These unaudited interim financial statements have been prepared by management of Spectral Diagnostics Inc. and have not been reviewed by the Company's auditors.

Spectral Diagnostics Inc.
Statements of Cash Flows - unaudited
For the nine months ended September 30, 2010 and 2009
_____________________________________________________________________________________________
(in thousands of dollars)

      3 Months Ended   9 Months Ended
      September 30   September 30
      2010
$
  2009
$
  2010
$
  2009
$
Cash provided by (used in)                  
                   
Operating activities
Loss and comprehensive loss for the period
Items not affecting cash
    (1,290)
 
(429)  
 
 
(4,503)
 
(1,534)
  Amortization
Amortization of commercial instruments included in cost of sales
Stock-based compensation expense
Interest on convertible notes payable
Unrealized loss on short-term investments
    155
10
-
24
-
  155
22
32
41
-
 
 
 
 
 
466
58
792
83
-
  478
65
32
123
91
Changes in non-cash working capital     150   (54)   (1,546)   (93)
      (951)   (233)   (4,650)   (838)
                   
Financing activities
Proceeds on issue of private placement
Proceeds on exercise of stock options
Settlement of convertible notes payable
     
-
17
-
 
-
-
-
 
 
 
 
 
17,608
49
1,100
 
-
-
-
      17   -   18,757   -
Investing activities
Purchase of property, plant and equipment
Purchase of commercial instruments
Purchase of  technology and trademarks
Decrease in short-term investments
Decrease in deferred revenue
     
(6)
(11)
-
-
  (32)
 
(31)
(7)
-
2,945
(43)
 
 
 
 
 
 
 
(61)
(38)
(502)
-
(97)
 
(85)
(32)
-
3,909
(129)
      (49)   2,864   (698)   3,663
                   
Increase (decrease) in cash and cash equivalents during
the period
    (983)   2,631   13,409   2,825
                   
Cash and cash equivalents - Beginning of period     17,336   491   2,944   297
                   
Cash and cash equivalents - End of period     16,353   3,122   16,353   3,122
                   
Non cash working capital and financing activities
Decrease in current portion of convertible notes payable
Settlement of convertible notes payable
   
-
-

-
-



(1,100)
1,100

-
-

These unaudited interim financial statements have been prepared by management of Spectral Diagnostics Inc. and have not been reviewed by the Company's auditors.



 

 

SOURCE Spectral Diagnostics Inc.

For further information:

Anthony Businskas
Executive Vice President 
and CFO
416-626-3233 ext. 2200
          Adam Peeler
Investor Relations
416-815-0700 ext. 225
apeeler@equicomgroup.com

 

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