About Spectral
Spectral is a Phase 3 company seeking U.S. FDA approval for its unique product for the treatment of patients with septic shock, Toraymyxin(TM) ("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(TM)), the only FDA cleared diagnostic for the risk of developing sepsis.
PMX is approved for therapeutic use in Japan and Europe, and has been used safely and effectively on more than 300,000 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 330,000 patients are diagnosed with severe sepsis and septic shock in North America each year.
Spectral, through its wholly owned subsidiary, Dialco Medical Inc., is also commercializing a new set of proprietary platforms addressing renal replacement therapy (RRT) across the dialysis spectrum. SAMI is targeting the acute RRT market, while DIMI is targeting the chronic RRT market. Dialco is currently pursuing regulatory approval for U.S. in-home use of DIMI, which is based on the same RRT platform as SAMI, but will be intended for home hemodialysis use. DIMI recently received its FDA 510k clearance for use in hospital and clinical settings, and obtained its Health Canada license for use within Canadian hospitals, clinics and in home.
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.
For further information, please contact:
David Waldman/Natalya
Chris Seto Ali Mahdavi Rudman
Capital Markets &
CEO Investor Relations US Investor Relations
Spinnaker Capital Markets Crescendo Communications,
Spectral Medical Inc. Inc. LLC
416-626-3233 ext. 2004 416-962-3300 212-671-1020
cseto@spectraldx.com am@spinnakercmi.com edt@crescendo-ir.com
--------------------------
Spectral Medical Inc.
Condensed Interim Consolidated
Statements of Financial Position
(unaudited)
-------------------------------------- ------------- ------------
(in thousands of Canadian dollars)
September 30, December 31,
2021 2020
$ $
-------------------------------------- ------------- ------------
Assets
Current assets
Cash 10,923 5,807
Trade and other receivables 567 260
Inventories 399 348
Prepayments and other assets 792 389
12,681 6,804
Non-current assets
Right-of-use-asset 555 625
Property and equipment 538 488
Intangible asset 233 246
Total assets 14,007 8,163
--------------------------------------- ------------- ------------
Liabilities
Current liabilities
Trade and other payables 1,335 2,141
Current portion of contract liabilities 729 676
Current portion of lease liability 91 85
--------------------------------------- ------------- ------------
2,155 2,902
Non-current liability
Lease liability 513 582
Non-current portion of contract
liabilities 4,846 5,348
--------------------------------------- ------------- ------------
Total liabilities 7,514 8,832
Shareholders' equity (deficiency)
Share capital 84,357 71,870
Contributed surplus 7,985 7,981
Share-based compensation 7,842 6,771
Warrants 2,251 2,418
Deficit (95,942) (89,709)
--------------------------------------- ------------- ------------
Total shareholders' equity (deficiency) 6,493 (669)
Total liabilities and shareholders'
equity (deficiency) 14,007 8,163
--------------------------------------- ------------- ------------
Spectral Medical
Inc.
Condensed
Interim
Consolidated
Statements of
Loss and
Comprehensive
Loss
(unaudited)
---------------- -------------------------- ----------------------------
(in thousands of
Canadian
dollars, except
for share and
per share data)
Three-months ended Nine-months ended
September 30, September 30,
2021 2020 2021 2020
$ $ $ $
---------------- ----------- ----------- ----------- -----------
Revenue 230 418 1,535 1,566
Expenses
Changes in
inventories of
finished goods
and
work-in-process 26 72 198 84
Raw materials
and consumables
used 108 47 273 351
Salaries and
benefits 826 1,014 3,640 3,505
Consulting and
professional
fees 913 418 2,075 3,612
Regulatory and
investor
relations 128 87 402 318
Travel and
entertainment 118 6 178 109
Facilities and
communication 50 95 196 262
Insurance 98 62 292 186
Depreciation and
amortization 71 79 223 223
Interest expense
on lease
liability 7 8 21 25
Foreign exchange
loss (gain) (57) 110 37 (144)
Other expense
(income) 9 (3) 99 (6)
Write down of
property and
equipment to
fair value - - 174 -
Gain on disposal
of property and
equipment - - (40) (8)
2,297 1,995 7,768 8,517
Loss and
comprehensive
loss for the
period (2,067) (1,577) (6,233) (6,951)
---------------- ----------- ----------- ----------- -----------
Basic and
diluted loss
per common
share (0.008) (0.007) (0.025) (0.030)
---------------- ----------- ----------- ----------- -----------
Weighted average
number of
common shares
outstanding --
basic and
diluted 260,928,039 236,605,745 247,267,326 231,109,027
---------------- ----------- ----------- ----------- -----------
Spectral
Medical Inc.
Condensed Interim Consolidated Statements of Changes
in Shareholders' (Deficiency) Equity
(unaudited)
-------------- -------------------- ----------- ------------- --------- -------- -------------
(in thousands of Canadian dollars)
Total
Shareholders'
Contributed Share-based (deficiency)
Issued capital surplus compensation Warrants Deficit equity
Number $ $ $ $ $ $
-------------- ----------- ------ ----------- ------------ -------- ------- -------------
Balance,
January 1,
2020 225,876,683 66,837 7,981 6,183 1,870 (80,611) 2,260
Public
offering 8,500,000 3,526 - - 788 - 4,316
Share options