TORONTO, ONTARIO--(Marketwired - Nov. 13, 2015) - This release corrects and replaces the release sent for Spectral Medical Inc. on November 13, 2015 at 8:00 AM ET. Spectral's financial tables have been appended to the end of the release.
Spectral Medical Inc., (TSX:EDT)(OTCQX:EDTXF), a Phase III company developing the first treatment for patients with septic shock that comprises a therapeutic device guided by a companion diagnostic, today announced its unaudited financial results for the third quarter ended September 30, 2015.
Financial Review
Revenue for the three months ended September 30, 2015 was $679,000 compared to $643,000 for the same period in the preceding year. For the nine months ended September 30, 2015 revenues were $2,374,000 compared to $2,265,000 in the first nine months of 2014. 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 September 30, 2015 amounted to $3,192,000 compared to $2,668,000 in 2014. Operating costs for the nine months ended were $9,566,000, representing a decrease of $364,000 from $9,930,000 for the first nine months of 2014. The year to date decrease is almost entirely attributable to lower costs for the EUPHRATES trial, resulting from fewer new sites being initiated into the trial and lower patient enrolment after the implementation of an additional exclusion criterion in April, 2014 that refined patient selection. The higher costs in the third quarter of 2015 were related to expenses incurred for the PMA submission and investigator meetings. 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 September 30, 2015, the Company reported a loss of $2,493,000 ($0.01 per share) compared to a loss of $ $1,403,000 ($0.01 per share) for the three months ended September 30, 2014. The loss for the nine months ended September 30, 2015 was $7,124,000 ($0.04 per share) compared to $7,029,000 ($0.05 per share) for the same nine month period in the prior year.
The Company concluded the third quarter of 2015 with cash and cash equivalents of $8,404,000 compared to $10,054,000 cash and cash equivalents on hand as of December 31, 2014.
The total number of shares outstanding for the Company was 190,686,405 as at September 30, 2015.
About Spectral
Spectral is a Phase III company seeking U.S. FDA approval for its lead theranostics product for the treatment of endotoxemic septic shock. Toraymyxin ™ (PMX) is a therapeutic hemoperfusion device that removes endotoxin, a main trigger of 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 for a medical device in the area of septic shock.
PMX has been approved for therapeutic use in Japan and Europe, and has been used 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 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 Statements of Financial Position |
| |
| (in thousands of Canadian dollars) |
| |
| |
September 30 2015 |
|
|
|
December 31 2014 |
|
| |
$ |
|
|
|
$ |
|
| |
Unaudited |
|
|
|
Audited |
|
| Assets |
|
|
|
|
|
|
| Current assets |
|
|
|
|
|
|
| Cash and cash equivalents |
8,404 |
|
|
|
10,054 |
|
| Trade and other receivables |
685 |
|
|
|
583 |
|
| Inventories |
255 |
|
|
|
166 |
|
| Prepayments |
245 |
|
|
|
185 |
|
| |
9,589 |
|
|
|
10,988 |
|
| Non-current assets |
|
|
|
|
|
|
| Property and equipment |
613 |
|
|
|
490 |
|
| Intangible asset |
366 |
|
|
|
384 |
|
| |
979 |
|
|
|
874 |
|
| |
|
|
|
|
|
|
| Total assets |
10,568 |
|
|
|
11,862 |
|
| |
|
|
|
|
|
|
| Liabilities |
|
|
|
|
|
|
| Current liabilities |
|
|
|
|
|
|
| Trade and other payables |
2,815 |
|
|
|
2,893 |
|
| Deferred revenue |
69 |
|
|
|
149 |
|
| Total liabilities |
2,884 |
|
|
|
3,042 |
|
| |
|
|
|
|
|
|
| Equity |
|
|
|
|
|
|
| Share capital |
53,011 |
|
|
|
46,879 |
|
| Contributed surplus |
7,849 |
|
|
|
7,849 |
|
| Other equity reserves |
3,621 |
|
|
|
3,542 |
|
| Deficit |
(56,797 |
) |
|
|
(49,450 |
) |
| Total equity |
7,684 |
|
|
|
8,820 |
|
| |
|
|
|
|
|
|
| Total liabilities and equity |
10,568 |
|
|
|
11,862 |
|
| |
|
|
|
|
|
|
| |
|
|
|
|
|
|
| Spectral Medical Inc. |
| Condensed Interim Statements of Loss and Comprehensive Loss |
| For the nine months ended September 30, 2015 and 2014 |
| (Unaudited) |
| |
| (in thousands of Canadian dollars, except for share and per share data) |
| |
|
|
|
|
|
|
| |
|
Three months ended |
|
|
Nine months ended |
|
| |
|
September 30 |
|
|
September 30 |
|
| |
|
2015 |
|
2014 |
|
|
2015 |
|
2014 |
|
| |
|
$ |
|
$ |
|
|
$ |
|
$ |
|
| |
|
|
|
|
|
|
|
|
|
|
| Revenue |
|
679 |
|
643 |
|
|
2,374 |
|
2,265 |
|
| |
|
|
|
|
|
|
|
|
|
|
| Expenses |
|
|
|
|
|
|
|
|
|
|
| Changes in inventories of finished goods and work- in-process |
|
28 |
|
30 |
|
|
108 |
|
230 |
|
| Raw materials and consumables used |
|
133 |
|
104 |
|
|
340 |
|
315 |
|
| Employee benefits |
|
846 |
|
840 |
|
|
2,665 |
|
2,709 |
|
| Consulting and professional fees |
|
1,451 |
|
1,310 |
|
|
4,693 |
|
5,200 |
|
| Product development |
|
16 |
|
- |
|
|
16 |
|
- |
|
| Regulatory and investor relations |
|
197 |
|
51 |
|
|
505 |
|
185 |
|
| Travel and entertainment |
|
329 |
|
162 |
|
|
721 |
|
726 |
|
| Depreciation and amortization |
|
43 |
|
49 |
|
|
130 |
|
172 |
|
| Foreign exchange loss (gain) |
|
8 |
|
2 |
|
|
(5 |
) |
49 |
|
| Other expenses |
|
141 |
|
120 |
|
|
393 |
|
344 |
|
| |
|
3,192 |
|
2,668 |
|
|
9,566 |
|
9,930 |
|
| |
|
|
|
|
|
|
|
|
|
|
| Operating loss |
|
(2,513 |
) |
(2,025 |
) |
|
(7,192 |
) |
(7,665 |
) |
| |
|
|
|
|
|
|
|
|
|
|
| Finance income |
|
20 |
|
13 |
|
|
68 |
|
27 |
|
| Loss and comprehensive loss before tax |
|
(2,493 |
) |
(2,012 |
) |
|
(7,124 |
) |
(7,638 |
) |
| |
|
|
|
|
|
|
|
|
|
|
| Deferred tax recovery |
|
- |
|
609 |
|
|
- |
|
609 |
|
| |
|
|
|
|
|
|
|
|
|
|
| Loss and comprehensive loss for the period |
|
(2,493 |
) |
(1,403 |
) |
|
(7,124 |
) |
(7,029 |
) |
| |
|
|
|
|
|
|
|
|
|
|
| Basic and diluted loss per common share |
|
(0.01 |
) |
(0.01 |
) |
|
(0.04 |
) |
(0.05 |
) |
| |
|
|
|
|
|
|
|
|
|
|
| Weighted average number of common shares outstanding |
|
190,830,571 |
|
168,846,613 |
|
|
187,168,709 |
|
146,049,893 |
|
| |
|
|
|
|
|
|
|
|
|
|
| |
| Spectral Medical Inc. |
| Condensed Interim Statements of Changes in Equity |
| For the nine months ended September 30, 2015 and 2014 |
| (Unaudited) |
| |
| (in thousands of Canadian dollars) |
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
|
Issued capital |
|
|
Contributed surplus |
|
Share-based compensation |
|
|
Warrants |
|
|
Deficit |
|
|
Total Equity |
|
| |
|
Number |
|
|
$ |
|
|
$ |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
| Balance, January 1, 2014 |
|
134,462,561 |
|
|
33,957 |
|
|
3,864 |
|
3,239 |
|
|
4,594 |
|
|
(39,958 |
) |
|
5,696 |
|
| Private placement |
|
45,051,186 |
|
|
12,816 |
|
|
- |
|
- |
|
|
- |
|
|
- |
|
|
12,816 |
|
| Share options exercised |
|
222,500 |
|
|
105 |
|
|
- |
|
(45 |
) |
|
- |
|
|
- |
|
|
60 |
|
| Warrants exercised |
|
994 |
|
|
1 |
|
|
- |
|
- |
|
|
- |
|
|
- |
|
|
1 |
|
| Warrants expiry, net of tax |
|
- |
|
|
- |
|
|
3,985 |
|
- |
|
|
(4,594 |
) |
|
- |
|
|
(609 |
) |
| Loss and comprehensive loss for the period |
|
- |
|
|
- |
|
|
- |
|
- |
|
|
- |
|
|
(7,029 |
) |
|
(7,029 |
) |
| Share-based compensation |
|
- |
|
|
- |
|
|
- |
|
295 |
|
|
- |
|
|
- |
|
|
295 |
|
| Balance, September 30, 2014 |
|
179,737,241 |
|
|
46,879 |
|
|
7,849 |
|
3,489 |
|
|
- |
|
|
(46,987 |
) |
|
11,230 |
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Balance, January 1, 2015 |
|
179,737,241 |
|
|
46,879 |
|
|
7,849 |
|
3,542 |
|
|
- |
|
|
(49,450 |
) |
|
8,820 |
|
| Private placement |
|
11,049,464 |
|
|
6,021 |
|
|
- |
|
- |
|
|
- |
|
|
- |
|
|
6,021 |
|
| Shares repurchased under NCIB |
|
(480,000 |
) |
|
(132 |
) |
|
- |
|
- |
|
|
- |
|
|
(223 |
) |
|
(355 |
) |
| Share options exercised |
|
379,700 |
|
|
243 |
|
|
- |
|
(104 |
) |
|
- |
|
|
- |
|
|
139 |
|
| Loss and comprehensive loss for the period |
|
- |
|
|
- |
|
|
- |
|
- |
|
|
- |
|
|
(7,124 |
) |
|
(7,124 |
) |
| Share-based compensation |
|
- |
|
|
- |
|
|
- |
|
183 |
|
|
- |
|
|
- |
|
|
183 |
|
| Balance, September 30, 2015 |
|
190,686,405 |
|
|
53,011 |
|
|
7,849 |
|
3,621 |
|
|
- |
|
|
(56,797 |
) |
|
7,684 |
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
| Spectral Medical Inc. |
| Condensed Interim Statements of Cash Flows |
| For the nine months ended September 30, 2015 and 2014 |
| (Unaudited) |
| |
| (in thousands of Canadian dollars) |
| |
| |
|
Nine months ended September 30 |
|
| |
|
2015 |
|
|
|
2014 |
|
| |
|
$ |
|
|
|
$ |
|
| Cash flow provided by (used in) |
|
|
|
|
|
|
|
| |
|
|
|
|
|
|
|
| Operating activities |
|
|
|
|
|
|
|
| Loss and comprehensive loss for the period |
|
(7,124 |
) |
|
|
(7,029 |
) |
| Adjustments for: |
|
|
|
|
|
|
|
| |
Depreciation on property and equipment |
|
112 |
|
|
|
154 |
|
| |
Amortization of intangible asset |
|
18 |
|
|
|
18 |
|
| |
Share-based compensation |
|
183 |
|
|
|
295 |
|
| |
Deferred tax recovery |
|
- |
|
|
|
(609 |
) |
| Changes in items of working capital: |
|
|
|
|
|
|
|
| |
Trade and other receivables |
|
(102 |
) |
|
|
(41 |
) |
| |
Inventories |
|
(89 |
) |
|
|
136 |
|
| |
Prepayments |
|
(60 |
) |
|
|
(100 |
) |
| |
Trade and other payables |
|
(78 |
) |
|
|
(1,104 |
) |
| |
Deferred revenue |
|
(80 |
) |
|
|
(79 |
) |
| Net cash used in operating activities |
|
(7,220 |
) |
|
|
(8,359 |
) |
| |
|
|
|
|
|
|
|
| Investing activities |
|
|
|
|
|
|
|
| Property and equipment expenditures |
|
(235 |
) |
|
|
(47 |
) |
| Net cash used in investing activities |
|
(235 |
) |
|
|
(47 |
) |
| |
|
|
|
|
|
|
|
| Financing activities |
|
|
|
|
|
|
|
| Private placement |
|
6,021 |
|
|
|
12,816 |
|
| Share options exercised |
|
139 |
|
|
|
60 |
|
| Warrants exercised |
|
- |
|
|
|
1 |
|
| Shares repurchased under the NCIB |
|
(355 |
) |
|
|
- |
|
| Net cash provided by financing activities |
|
5,805 |
|
|
|
12,877 |
|
| |
|
|
|
|
|
|
|
| (Decrease)increase in cash and cash equivalents |
|
(1,650 |
) |
|
|
4,471 |
|
| |
|
|
|
|
|
|
|
| Cash and cash equivalents, beginning of period |
|
10,054 |
|
|
|
7,229 |
|
| Cash and cash equivalents, end of period |
|
8,404 |
|
|
|
11,700 |
|