TSX:EDT / OTC:EDTXF - Spectral Medical Inc.

May 12, 2016 08:00 ET

Spectral Announces First Quarter Results

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.
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.

MANAGEMENT?S DISCUSSION & ANALYSIS
(All figures are expressed in thousands of Canadian dollars)

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.

This MD&A is dated March 29, 2016 and should be read in conjunction with the consolidated financial statements for the years ended December 31, 2015, and December 31, 2014.

Spectral Medical Files Expanded Access Protocol With FDA For Toraymyxin(TM) Septic Shock Treatment
Four patients remaining to enroll in the EUPHRATES clinical trial Company expects to announce trial results and submit final PMA module before end of 2016

Tuesday, May 31, 2016

Spectral Medical Files Expanded Access Protocol With FDA for Toraymyxin(TM) Septic Shock Treatment
08:00 EDT Tuesday, May 31, 2016
TORONTO, ONTARIO--(Marketwired - May 31, 2016) - Spectral Medical Inc. ("Spectral" or the "Company"), (TSX:EDT) (OTCQX:EDTXF), a Phase III Company advancing a precision treatment targeting specific patients at high risk of death from septic shock, today announced that it has filed a protocol and is in discussions with the U.S. Food and Drug Administration (FDA) for Expanded Access of Toraymyxin?, the Company's investigational therapeutic hemoperfusion device that removes endotoxin from the bloodstream. The Company also announced several significant updates and milestones achieved on its path to potential regulatory approval and anticipated commercial availability of its treatment in the United States.

The Expanded Access program, sometimes referred to as Compassionate Use, if approved by the FDA, would begin upon the completion of patient enrollment - expected no later than June 30, 2016 - at most of the 29 U.S. hospitals currently participating in the Phase III EUPHRATES clinical trial. 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 (EAA?), would be eligible for the treatment. A similar program is planned for Canada, where there are 12 hospitals engaged in the clinical trial.

"Currently, there is no approved treatment for patients in septic shock, the most advanced and lethal stage of sepsis, and clinicians are left with very few options to treat the sickest of patients," said Dr. Paul Walker, President and CEO of Spectral. "Toraymyxin? represents a new solution for sepsis treatment and has been used on more than 150,000 patients outside of North America over the course of more than a decade. Provided the FDA approves our Expanded Access program, this treatment could be available soon for use in select patients at participating clinical trial locations in the United States."

Spectral also provided guidance today on several significant clinical and regulatory milestones:

As of today, only four patients remain to be enrolled in the EUPHRATES trial, which is fully on track to be completed by no later than June 30, 2016.

The FDA has accepted Spectral's statistical analysis plan for the PMA submission of Toraymyxin?. Subsequent to analysis of the trial data, the Company expects to announce primary end point results around the end of September 2016 and will then submit the last module of the PMA. The first three modules have already been submitted to the FDA. Assuming positive clinical data and barring any unexpected delays, Spectral anticipates a decision from the FDA as early as the first quarter of 2017.

The Company has submitted a 510K to the FDA for a proprietary stand-alone pump dedicated to the Toraymyxin? therapy that would facilitate treatment delivery in the Intensive Care Unit (ICU) and increase options available to clinicians. The pump is also designed to provide an open platform for other hemoperfusion cartridges and to deliver continuous renal replacement therapy when indicated. A decision is expected in Q3 2016 and, if approved, the pump will be available for use in the Expanded Access program where needed.