EDTXF Spectral Medical Inc (PK)

SPECTRAL ANNOUNCES THIRD QUARTER 2012 RESULTS

 

TORONTO, Canada – November 14, 2012 – Spectral Diagnostics Inc., (TSX:SDI) (OTCQX:
DIAGF), a Phase
III company developing the first theranostic treatment for patients with septic
shock, today announced its financial
results for the third quarter ended September 30, 2012.

 

Third Quarter Highlights:

 

·        
Announced that the U.S. Food and Drug Administration
approved an amended protocol for Spectral’s Phase III EUPHRATES trial, which
will now have two planned interim analyses instead of one. Spectral requested
the amendment, including the strategy for two interim analyses. The first
interim analysis, for safety, will occur when 76 randomized patients have been
followed for 28 days. Seventy three patients have been randomized into the
trial at 25 sites as of October 31, 2012. The second interim analysis - anticipated
in the first half of 2014 - will occur after 184 randomized patients have been
followed for 28 days. At the second analysis, the Data Safety Monitoring Board
will advise Spectral on the trial’s safety and efficacy. Stopping rules for
efficacy are included in the second interim analysis.

 

·        
Continued enrolling patients into the Company’s Phase
III EUPHRATES trial at a per site rate that is higher than previous sepsis
trials. Directed by the Company's Endotoxin Activity Assay (EAA™), which is the
only FDA-cleared diagnostic for the risk of developing sepsis, Spectral's
EUPHRATES trial is currently targeted to enroll 306 evaluable patients at up to
60 sites in North America. Contingent on
maintaining current enrolment rates and timely site start ups, the trial should
be fully enrolled by the end of 2014.

 

·        
Announced an exclusive distribution agreement with
Toray International Italy S.r.l. - a subsidiary of Toray Industries, Inc. - to
sell the Company’s Endotoxin Activity Assay in combination with Toraymyxin in Saudi Arabia and Turkey. The expansion of commercial
jurisdictions with Toray further confirms the outstanding market opportunity
for the Company’s unique theranostic treatment for septic shock.

 

·        
Concluded the reporting period with approximately $12.2
million in cash, cash equivalents and short- term investments.  

 

 

“As the enrollment of patients in our Phase III trial
progresses, we are closing in on a number of inflection points for our current and
prospective investors,” said Dr. Paul Walker, President and CEO of Spectral
Diagnostics. “In addition, there continues to be a significant unmet medical
need in the area of severe sepsis, and we feel we are at the forefront of
meeting that need with our theranostic treatment.”     

 

Financial Review

 

Revenue for the three months ended
September 30, 2012 was $667,000 compared to $489,000
for the same period in the preceding
year. For the nine months ended September 30, 2012 revenue was $1,942,000
compared to $1,802,000 for the same period in 2011.

 

For the second quarter ended September
30, 2012, the Company reported a loss of $2,077,000 compared to a loss of $1,632,000
for the corresponding period in 2011. For the nine months ended September 30, 2012, Spectral
reported a loss of $6,476,000 compared to $4,807,000 for the same period in
2011. The Company’s loss was greater for the three and nine months of 2012 due
to higher costs for its Phase III EUPHRATES trial.  

 

Cash, cash equivalents and
short-term investments on hand at September 30, 2012 were $12.2 million. Cash
was used during the quarter ended September 30, 2012 to fund operations and for
working capital purposes.

The total
number of shares outstanding for the Company was 113,883,394 as at September
30, 2012.

About Spectral Diagnostics

Spectral is a Phase III company seeking U.S. FDA
approval for its lead theranostics product for the treatment of severe sepsis with
septic shock. Toraymyxin 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 first theranostics trial in the area of sepsis.

 

Toraymyxin has been approved for therapeutic use
in Japan and Europe, and has been used safely and effectively in more
than 100,000 patients to date. In March 2009, Spectral obtained the exclusive
development and commercial rights in the U.S.
for Toraymyxin, and in November 2010, signed an exclusive distribution agreement
for this product in Canada.
More than 250,000 patients are diagnosed with severe sepsis and septic shock in
North America each year, representing a
greater than $1 billion market opportunity for Spectral. Spectral is listed on
the Toronto Stock Exchange under the symbol SDI, and on the OTCQX under the
symbol DIAGF. 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.

 

For further information please contact:

 

Anthony Businskas Executive Vice President and CFO 416-626-3233 ext. 2200

Adam Peeler Investor Relations TMX Equicom 416-815-0700 ext. 225 apeeler@tmxequicom.com

 

 

 

 

 

 

 

 

 

 

 

Spectral Diagnostics Inc.

 

(in
thousands of Canadian dollars)

 

	Note	September 30 2012		December 31 2011
		$		$
		Unaudited		Audited
Assets
Current assets
Cash and cash equivalents		7,094		13,470
Short-term investment		5,137		5,086
Trade and other  receivables		611		515
Inventories		213		295
Prepayments		162		407
		13,217		19,773
Non-current assets
Property, plant and equipment		488		419
Intangible assets		441		459
		929		878
Total assets		14,146		20,651
Liabilities
Current liabilities
Trade and other  payables		1,507		1,610
Deferred revenue		26		102
Total liabilities		1,533		1,712
Equity
Share capital		27,101		27,101
Contributed surplus		3,864		3,864
Other equity reserves	8	8,232		8,082
Deficit		(26,584)		(20,108)
Total equity		12,613		18,939
Total liabilities and equity		14,146		20,651

 

 

 

 

 

 

 

 

 

 

 

Spectral Diagnostics Inc.

 

(in
thousands of Canadian dollars, except for share and per share data)

 

		Three months ended			Nine  months ended
		September  30			September 30
	Note	2012	2011		2012	2011
		$	$		$	$
Revenue		667	489		1,942	1,802
Other income		25	19		91	69
Expenses
Changes in inventories of finished goods and work- in-process		64	63		208	201
Raw materials and consumables used		135	59		344	176
Employee benefits	8, 10	598	575		2,004	1,988
Consulting and professional fees		1,352	700		3,598	2,047
Management services	11	173	375		923	1,125
Regulatory and investor relations		112	68		334	205
Travel and entertainment		153	176		612	422
Depreciation and amortization		57	49		163	263
Foreign exchange (gain)loss		16	(18)		20	(1)
Other expenses		127	110		355	301
		2,787	2,157		8,561	6,727
Operating loss		(2,095)	(1,649)		(6,528)	(4,856)
Finance  income		18	17		52	49
Loss and comprehensive loss for the period		(2,077)	(1,632)		(6,476)	(4,807)
Basic and diluted loss per common share		(0.02)	(0.02)		(0.06)	(0.06)
Weighted average number of common shares outstanding
		113,883,394	88,158,757		113,883,394	83,114,164

 

 

 

 

 

 

 

 

Spectral
Diagnostics Inc.

Condensed
Interim Statement of Changes in Equity

(in thousands of Canadian dollars, except number of shares)

 

	Note	Issued capital		Contributed surplus	Share-based compensation	Warrants	Deficit	Total  equity
		Number	$	$	$	$	$	$
Balance, January 1, 2011		80,550,061	17,538	3,696	2,722	5,311	(13,395)	15,872
Loss and comprehensive loss  for the period		-	-	-	-	-	(4,807)	(4,807)
Private placement		33,333,333	9,607	-	-	-	-	9,607
Share-based compensation	8, 10	-	-	-	188	-	-	188
Balance, September  30, 2011		113,883,394	27,145	3,696	2,910	5,311	(18,202)	20,860
Balance, January 1, 2012		113,883,394	27,101	3,864	2,939	5,143	(20,108)	18,939
Loss and comprehensive loss for the period		-	-	-	-	-	(6,476)	(6,476)
Share-based compensation	8, 10	-	-	-	150	-	-	150
Balance, September 30, 2012		113,883,394	27,101	3,864	3,089	5,143	(26,584)	12,613