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Spectral Announces Second Quarter Results


/EINPresswire.com/ -- TORONTO, ONTARIO -- (Marketwired) -- 08/12/16 -- 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 second quarter ended June 30, 2016.

Financial Review

Revenue for the three months ended June 30, 2016 was $870,000 compared to $818,000 for the same period in the preceding year. For the six months ended June 30, 2016 revenues were $1,932,000 compared to $1,695,000 in the first half of 2015. 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, 2016 amounted to $4,393,000 compared to $3,242,000 in 2015. Operating costs for the six months ended were $8,462,000, an increase of $2,088,000 from $6,374,000 for the first six months of 2015. The increase is almost entirely attributable to higher costs for the EUPHRATES trial, resulting from completion of patient enrolment, collection of data, and preparation of its final submission to the U. S. Food and Drug Administration (FDA). Trial related expenses are expected to decline significantly starting in the third quarter. Apart from clinical trial activities, the Company continues to maintain a low cost operating structure for its base business operations.

For the three months ended June 30, 2016, the Company reported a loss of $3,498,000 ($0.02 per share) compared to a loss of $2,400,000 ($0.01 per share) for the three months ended June 30, 2015. The loss for the six months ended June 30, 2016 was $6,492,000 ($0.03 per share) compared to $4,722,000 ($0.03 per share) for the same six month period in the prior year.

The Company concluded the second quarter of 2016 with cash on hand of $10,044,000 compared to $6,369,000 as of December 31, 2015.

The total number of shares outstanding for the Company was 206,733,209 as at June 30, 2016.

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)

                                                       June 30  December 31
                                                          2016         2015
                                                             $            $
----------------------------------------------------------------------------

Assets
Current assets
Cash                                                    10,044        6,369
Trade and other receivables                                752          630
Inventories                                                436          243
Prepayments and other assets                               264          141
----------------------------------------------------------------------------
                                                        11,496        7,383
Non-current assets
Property and equipment                                     714          717
Intangible asset                                           347          359
----------------------------------------------------------------------------
                                                         1,061        1,076

----------------------------------------------------------------------------
Total assets                                            12,557        8,459
----------------------------------------------------------------------------
----------------------------------------------------------------------------

Liabilities
Current liabilities
Trade and other payables                                 3,387        2,850
Deferred revenue                                           105          176
----------------------------------------------------------------------------
Total liabilities                                        3,492        3,026

Equity
Share capital                                           62,915       53,058
Contributed surplus                                      7,849        7,849
Other equity reserves                                    3,990        3,723
Deficit                                                (65,689)     (59,197)
----------------------------------------------------------------------------
Total equity                                             9,065        5,433

----------------------------------------------------------------------------
Total liabilities and equity                            12,557        8,459
----------------------------------------------------------------------------
----------------------------------------------------------------------------


Spectral Medical Inc.
Condensed Interim Consolidated Statements of Loss and Comprehensive Loss
For the six months ended June 30, 2016 and 2015
(Unaudited)
----------------------------------------------------------------------------

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

                                 Three months ended        Six months ended
                                            June 30                 June 30
                                   2016        2015        2016        2015
                                                  $                       $
----------------------------------------------------------------------------

Revenue                             870         818       1,932       1,695
----------------------------------------------------------------------------

Expenses
Changes in inventories of
 finished goods and work-
 in-process                          58          56          83          80
Raw materials and
 consumables used                    95         107         298         207
Employee benefits                   969         906       2,210       1,910
Product development                  67           -          67           -
Consulting and professional
 fees                             2,555       1,670       4,610       3,242
Regulatory and investor
 relations                          191         138         326         308
Travel and entertainment            261         189         470         392
Depreciation and
 amortization                        49          44          91          87
Foreign exchange loss (gain)         15           4          30         (13)
Other expenses                      133         128         277         252
----------------------------------------------------------------------------
                                  4,393       3,242       8,462       6,465

----------------------------------------------------------------------------
Operating loss                   (3,523)     (2,424)     (6,529)     (4,770)
----------------------------------------------------------------------------

Finance income                       25          24          38          48
----------------------------------------------------------------------------

----------------------------------------------------------------------------
Loss and comprehensive loss
 for the period                  (3,498)     (2,400)     (6,492)     (4,722)
----------------------------------------------------------------------------
----------------------------------------------------------------------------

Basic and diluted loss per
 common share                     (0.02)      (0.01)      (0.03)      (0.03)
----------------------------------------------------------------------------
----------------------------------------------------------------------------

Weighted average number of
 commonshares outstanding   206,733,209 190,803,548 202,334,393 185,307,431
----------------------------------------------------------------------------
----------------------------------------------------------------------------


Spectral Medical Inc.
Condensed Interim Consolidated Statements of Changes in Equity
For the six months ended June 30, 2016 and 2015
(Unaudited)
----------------------------------------------------------------------------

(in thousands of Canadian dollars)
                                                                 Contributed
                                       Issued capital                surplus
                                       Number              $               $
----------------------------------------------------------------------------
Balance, January
 1, 2015                          179,737,241         46,879           7,849
Private
 placement                         11,049,464          6,021               -
Shares
 repurchased
 under NCIB                           (90,000)           (23)
Share options
 exercised                            355,950            231               -
Loss and
 comprehensive
 loss for the
 period                                     -              -               -
Share-based
 compensation                               -              -               -
----------------------------------------------------------------------------
Balance, June
 30, 2015                         191,052,655         53,108           7,849
----------------------------------------------------------------------------

Balance, January
 1, 2016                          190,771,405         53,058           7,849
Bought deal
 prospectus
 offering                          15,106,804          9,399               -
Share options
 exercised                            855,000            458               -
Loss and
 comprehensive
 loss for the
 period                                     -              -               -
Share-based
 compensation                               -              -               -
----------------------------------------------------------------------------
Balance, June
 30, 2016                         206,733,209         62,915           7,849
----------------------------------------------------------------------------



Spectral Medical Inc.
Condensed Interim Consolidated Statements of Changes in Equity
For the six months ended June 30, 2016 and 2015
(Unaudited)
---------------------------------------------------------------------------

(in thousands of Canadian dollars)
                   Share-based
                  compensation        Warrants       Deficit   Total equity
                             $               $             $              $
----------------------------------------------------------------------------
Balance, January
 1, 2015                 3,542               -       (49,450)         8,820
Private
 placement                   -               -                        6,021
Shares
 repurchased
 under NCIB                                              (32)           (55)
Share options
 exercised                 (99)              -                          132
Loss and
 comprehensive
 loss for the
 period                      -               -        (4,722)        (4,722)
Share-based
 compensation              228               -             -            228
----------------------------------------------------------------------------
Balance, June
 30, 2015                3,671               -       (54,204)        10,424
----------------------------------------------------------------------------

Balance, January
 1, 2016                 3,723               -       (59,197)         5,433
Bought deal
 prospectus
 offering                    -               -             -          9,399
Share options
 exercised                (192)              -             -            266
Loss and
 comprehensive
 loss for the
 period                      -               -        (6,492)        (6,492)
Share-based
 compensation              459               -             -            459
----------------------------------------------------------------------------
Balance, June
 30, 2016                3,990               -       (65,689)         9,065
----------------------------------------------------------------------------


Spectral Medical Inc.
Condensed Interim Consolidated Statements of Cash Flows
For the six months ended June 30, 2016 and 2015
(Unaudited)
----------------------------------------------------------------------------

(in thousands of Canadian dollars)
                                                                 Six months
                                                                      ended
                                                        2016           2015
                                                           $              $
----------------------------------------------------------------------------
Cash flow provided by (used in)

Operating activities
Loss and comprehensive loss for the period            (6,492)        (4,722)
Adjustments for:
  Depreciation on property and equipment                  79             75
  Amortization of intangible asset                        12             12
  Share-based compensation                               459            228
  Loss on disposal of property and equipment               4
Changes in items of working capital :
  Trade and other receivables                           (122)          (197)
  Inventories                                           (193)          (101)
  Prepayments and other assets                          (123)          (135)
  Trade and other payables                               537           (110)
  Deferred revenue                                       (71)           (75)
----------------------------------------------------------------------------
Net cash used in operating activities                 (5,910)        (5,025)

Investing activities
Property and equipment expenditures                      (80)          (191)
----------------------------------------------------------------------------
Net cash used in investing activities                    (80)          (191)

Financing activities
Bought deal prospectus offering                        9,399              -
Private placement                                          -          6,021
Share options exercised                                  266            132
Shares repurchased under NCIB                              -            (55)
----------------------------------------------------------------------------
Net cash provided by financing activities              9,665          6,098

Increase in cash                                       3,675            882

Cash, beginning of period                              6,369         10,054
----------------------------------------------------------------------------
Cash, end of period                                   10,044         10,936
----------------------------------------------------------------------------
----------------------------------------------------------------------------

Contacts:
Anthony Businskas
Executive Vice President and CFO
Spectral Medical Inc.
416-626-3233 ext. 2200
tbusinskas@spectraldx.com

Ali Mahdavi
Capital Markets & Investor Relations
416-962-3300
am@spinnakercmi.com


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