Spectral Announces Second Quarter Results
(firmenpresse) - 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
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.
Contacts:
Anthony Businskas
Executive Vice President and CFO
Spectral Medical Inc.
416-626-3233 ext. 2200
Ali Mahdavi
Capital Markets & Investor Relations
416-962-3300
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Datum: 12.08.2016 - 12:00 Uhr
Sprache: Deutsch
News-ID 488848
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TORONTO, ONTARIO
Kategorie:
Medical Devices
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