TORONTO, ONTARIO–(Marketwired – May 12, 2017) – 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, 2017.
Financial Review
Revenue for the three months ended March 31, 2017 was $941,000 compared to $1,062,000 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, 2017 were $1,903,000 compared to $4,069,000 in 2016. As the Company’s Phase III clinical trial nears its conclusion, the related expenses have declined significantly. The Company continues to maintain a low cost operating structure for its base business operations and believes that it has adequate cash on hand to fund its regulatory program and operations through the end of the first quarter of 2018.
Loss for the quarter ended March 31, 2017 was $962,000 ($0.005 per share) compared to $2,994,000 ($0.02 per share) for the same quarter last year.
The Company concluded the first quarter of 2017 with cash on hand of $3,714,000 compared to $5,080,000 as of December 31, 2016.
The total number of shares outstanding for the Company was 207,165,587 as at March 31, 2017.
Business Update
The Company expects to file the fourth and final module of its PMA submission to the United States Food and Drug Administration in the second quarter and plans to make an announcement when the submission has been filed and to disclose further clinical data at that time.
The Company also expects to submit a manuscript for publication in a major medical journal and to present trial results at a major medical conference before the end of June 2017.
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.
| Spectral Medical Inc. | ||||||
| Condensed Interim Consolidated Statements of Financial Position | ||||||
| (Unaudited) | ||||||
| (in thousands of Canadian dollars) | ||||||
| March 31 | December 31 | |||||
| 2017 | 2016 | |||||
| $ | $ | |||||
| Assets | ||||||
| Current assets | ||||||
| Cash | 3,714 | 5,080 | ||||
| Trade and other receivables | 792 | 642 | ||||
| Inventories | 259 | 244 | ||||
| Prepayments and other assets | 299 | 166 | ||||
| 5,064 | 6,132 | |||||
| Non-current assets | ||||||
| Property and equipment | 667 | 634 | ||||
| Intangible asset | 328 | 334 | ||||
| 995 | 968 | |||||
| Total assets | 6,059 | 7,100 | ||||
| Liabilities | ||||||
| Current liabilities | ||||||
| Trade and other payables | 758 | 1,112 | ||||
| Deferred revenue | 131 | 166 | ||||
| Total liabilities | 889 | 1,278 | ||||
| Equity | ||||||
| Share capital | 63,084 | 63,084 | ||||
| Contributed surplus | 7,849 | 7,849 | ||||
| Share-based compensation | 4,413 | 4,103 | ||||
| Warrants | 132 | 132 | ||||
| Deficit | (70,308 | ) | (69,346 | ) | ||
| Total equity | 5,170 | 5,822 | ||||
| Total liabilities and equity | 6,059 | 7,100 | ||||
| Spectral Medical Inc. | ||||||
| Condensed Interim Consolidated Statements of Loss and Comprehensive Loss For the three months ended March 31, 2017 and 2016 | ||||||
| (Unaudited) | ||||||
| (in thousands of Canadian dollars, except for share and per share data) | ||||||
| 2017 | 2016 | |||||
| $ | $ | |||||
| Revenue | 941 | 1,062 | ||||
| Expenses | ||||||
| Changes in inventories of finished goods and work-in-process | 15 | 25 | ||||
| Raw materials and consumables used | 52 | 203 | ||||
| Employee benefits | 1,080 | 1,153 | ||||
| Consulting and professional fees | 320 | 2,071 | ||||
| Product development | 50 | – | ||||
| Regulatory and investor relations | 96 | 207 | ||||
| Travel and entertainment | 86 | 209 | ||||
| Depreciation and amortization | 54 | 42 | ||||
| Foreign exchange loss | 3 | 15 | ||||
| Other expenses | 147 | 144 | ||||
| 1,903 | 4,069 | |||||
| Operating loss | (962 | ) | (3,007 | ) | ||
| Finance income | – | 13 | ||||
| Loss and comprehensive loss for the period | (962 | ) | (2,994 | ) | ||
| Basic and diluted loss per common share | (0.005 | ) | (0.02 | ) | ||
| Weighted average number of common shares outstanding | 207,165,587 | 198,015,803 | ||||
| Spectral Medical Inc. | |||||||||||||||||
| Condensed Interim Consolidated Statements of Changes in Equity For the three months ended March 31, 2017 and 2016 | |||||||||||||||||
| (Unaudited) | |||||||||||||||||
| (in thousands of Canadian dollars) | |||||||||||||||||
| Contributed | Share-based | Total | |||||||||||||||
| Issued capital | surplus | compensation | Warrants | Deficit | equity | ||||||||||||
| Number | $ | $ | $ | $ | $ | $ | |||||||||||
| 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 | |||||||||
| Balance, January 1, 2017 | 207,165,587 | 63,084 | 7,849 | 4,103 | 132 | (69,346 | ) | 5,822 | |||||||||
| Loss and comprehensive loss for the period | – | – | – | – | – | (962 | ) | (962 | ) | ||||||||
| Share-based compensation | – | – | – | 310 | – | – | 310 | ||||||||||
| Balance, March 31, 2017 | 207,165,587 | 63,084 | 7,849 | 4,413 | 132 | (70,308 | ) | 5,170 | |||||||||
| Spectral Medical Inc. | |||||||
| Condensed Interim Consolidated Statements of Cash Flows For the three months ended March 31, 2017 and 2016 | |||||||
| (Unaudited) | |||||||
| (in thousands of Canadian dollars) | |||||||
| 2017 | 2016 | ||||||
| $ | $ | ||||||
| Cash flow provided by (used in) | |||||||
| Operating activities | |||||||
| Loss and comprehensive loss for the period | (962 | ) | (2,994 | ) | |||
| Adjustments for: | |||||||
| Depreciation on property and equipment | 48 | 35 | |||||
| Amortization of intangible asset | 6 | 6 | |||||
| Share-based compensation | 310 | 359 | |||||
| Changes in items of working capital : | |||||||
| Trade and other receivables | (150 | ) | (256 | ) | |||
| Inventories | (15 | ) | (82 | ) | |||
| Prepayments and other assets | (133 | ) | (160 | ) | |||
| Trade and other payables | (354 | ) | (22 | ) | |||
| Deferred revenue | (35 | ) | (9 | ) | |||
| Net cash used in operating activities | (1,285 | ) | (3,123 | ) | |||
| Investing activities | |||||||
| Property and equipment expenditures | (81 | ) | (53 | ) | |||
| Net cash used in investing activities | (81 | ) | (53 | ) | |||
| Financing activities | |||||||
| Bought deal prospectus offering | – | 9,402 | |||||
| Share options exercised | – | 266 | |||||
| Net cash provided by financing activities | – | 9,668 | |||||
| (Decrease)increase in cash | (1,366 | ) | 6,492 | ||||
| Cash, beginning of period | 5,080 | 6,369 | |||||
| Cash, end of period | 3,714 | 12,861 | |||||
Anthony Businskas
Executive Vice President and CFO
416-626-3233 ext. 2200
tbusinskas@spectraldx.com
Ali Mahdavi
Capital Markets & Investor Relations
416-962-3300
am@spinnakercmi.com