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TSX:EDT / OTC:EDTXF - Spectral Medical Inc.
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.
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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.
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This Management’s Discussion & Analysis (“MD&A”) for the year ended December 31, 2015 has been prepared to help investors understand the financial performance of the Company in the broader context of the Company’s strategic direction, the risks and opportunities as understood by management, and the key success factors that are relevant to the Company’s performance. Management has prepared this document in conjunction with its broader responsibilities for the accuracy and reliability of the financial statements, as well as the development and maintenance of appropriate information systems and internal controls to ensure that the financial information is complete and reliable. The Finance and Audit Committee of the Board of Directors has reviewed this document and all other publicly reported financial information for integrity, usefulness, reliability and consistency.
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The Expanded Access program, sometimes referred to as Compassionate Use, can now begin at certain of the 29 U.S. hospitals that had participated in the recently completed Phase III EUPHRATES clinical trial and have agreed to be part of this program. Patients who meet the clinical criteria for septic shock, are in multiple organ failure and who have elevated levels of endotoxin in the blood, as measured by the Company's FDA cleared Endotoxin Activity Assay (EAATM), would be eligible for the treatment. A similar program is planned for Canada, where there were 12 hospitals engaged in the clinical trial.
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"As we move to complete our PMA submission for ToraymyxinTM with the FDA later this year, physicians in our clinical trial locations can now have immediate access to a therapy that has been used on more than 150,000 patients outside of North America for more than a decade,” said Dr. Paul Walker, President and CEO of Spectral. “Prior clinical research has demonstrated that removing endotoxin from the blood with ToraymyxinTM can result in positive patient outcomes and a reduction in mortality.”
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