Spectral Medical Inc. (“Spectral” or the “Company”) (TSX:
EDT), a late stage theranostic company advancing
therapeutic options for sepsis and septic shock, as well as
commercializing a new proprietary platform targeting the renal
replacement therapy market through its wholly-owned subsidiary
Dialco Medical Inc. (
“Dialco”), today announced
its financial results for the fourth quarter and for the year ended
December 31, 2021 and provided a corporate update.
Chris Seto, CEO of Spectral Medical, commented,
“2021 was a foundational year for Spectral and Dialco as we
reported key achievements, both clinically and operationally,
despite the headwinds presented by several waves of COVID
variants. While clinical enrollment activity continued to be
negatively impacted, the Company responded quickly and implemented
key tools and changes to aide in advancing our clinical
programs. On the Tigris front, we recently implemented the
FDA protocol amendment allowing sequential organ failure assessment
(SOFA) scoring as an inclusion criteria into the study, in
conjunction with a full complement of Tigris sites engaged.
Along with other sub-study activity, Tigris is well positioned for
an expedient and positive outcome. Tigris enrollment now
stands at 30 patients randomized out of the 150 total patients to
be enrolled. While the sample size is small, we remain highly
encouraged by the preliminary mortality outcome data, which
continues to exceed expectations. Assuming there is no significant
recurrence of COVID-19 variants, we remain committed to completing
Tigris trial enrollment in mid-2023.”
“In terms of our Dialco subsidiary, we have
experienced site initiation challenges related to staffing
shortages across the dialysis clinic industry. Nevertheless, we
have taken a number of steps to help us advance the DIMI trial.
In January 2022, the FDA approved an amendment to the DIMI
home hemodialysis study that simplifies the protocol and allows for
extended use for patients, which should improve enrollment by
addressing both patient and clinical logistics flow issues
experienced throughout the industry. We have progressed to
the site contracting phase and anticipate initial patient enrolment
into our DIMI usability trial for home use in the third quarter of
2022.”
Dr. John Kellum, Chief Medical Officer of
Spectral, further noted, “We are witnessing the positive impact,
including robust use, of the new SOFA scoring as an inclusion
criteria for screening in the Tigris trial, especially in the first
quarter of 2022. Additionally, the initiation of the EDEN sub-study
could have a positive impact on recruitment as these patients will
be considered for the Tigris study. Moreover, our recent
FDA-approved amendment to our DIMI study simplifies the protocol
and allows for extended use for patients, which could have a
positive impact on enrollment.”
Mr. Seto concluded, “Overall, we remain very
encouraged by the outlook for the business. We believe our
clinical programs are on solid footing, backed by great
technologies. Our relationship with our exclusive
distribution partner for PMX in North America continues to
strengthen, as we work closely on pre-launch activities including
developing a broad campaign to bring endotoxins to the forefront
and more broadly explain their role as it relates to the pathology
of certain septic shock. At the same time, we continue to
strengthen our leadership and advisory resources, with the recent
appointment of Blair McInnis as CFO of Spectral, and the formation
of our Dialco Medical Advisory Board comprised of world-class home
hemodialysis experts. We will continue to add key personnel –
specifically executive leadership at Dialco in the coming months,
which will help accelerate both our clinical and commercial
activities around both the DIMI and SAMI devices. In terms of
the SAMI device, we are focused on deploying devices in the field
and gaining clinical awareness, and we are seeing a robust pipeline
of SAMI activities, which we look to capitalize on in 2022. In the
meantime, we continue to carefully manage expenses and have
maintained a solid balance sheet. As a result, we believe
Spectral is well positioned in both the sepsis and home
hemodialysis markets, both of which represent multi-billion-dollar
addressable markets.”
Financial
ReviewRevenue for the three months ended December
31, 2021 was $517,000 compared to $535,000 for the same three month
period last year. Revenue for the year ended December 31, 2021 was
$2,052,000 compared to $2,101,000 for the prior year, representing
a decrease of $49,000, or 2%. The majority of the decrease is due
to the decrease in royalty revenue. This was mitigated by an
increase in product revenue, and revenue from the exclusive
distribution agreement with Baxter International Inc.
(“Baxter”).
For the quarter ended December 31, 2021, the
Company reported operating costs of $3,069,000 compared to
$2,682,000 for the corresponding period in 2020. Operating costs
for the year ended December 31, 2021 amounted to $10,837,000
compared to $11,199,000 in 2020. The decrease relates to
non-recurring fees payable to a financial advisory services firm
incurred in the first quarter of 2020, relating to a legacy
financial advisory agreement. In addition, it incurred
approximately $275,000 in professional fees in connection with a
withdrawn prospectus offering in early March 2020. The decrease was
partially offset by increased clinical trial activity for Tigris,
EDEN and the DIMI usability trials, as well as the fees from a
professional employment organization that manages Dialco’s field
force in the United States.
The Company continues to maintain a low cost
operating structure for its base business operations. The
Company anticipates its operating costs to increase throughout 2022
as Spectral’s Tigris trial enrolment is expected to increase
significantly, combined with incremental costs associated with
Dialco’s upcoming usability trial for DIMI and the increase in
field resources for the marketing and commercialization activities
of its RRT devices.
Loss for the quarter ended December 31, 2021 was
$2,552,000 ($0.010 per share) compared a loss of $2,147,000 ($0.009
per share) for the same quarter last year. For the year ended
December 31, 2021, the Company reported a loss of $8,785,000,
($0.03 per share), compared to a loss of $9,098,000 ($0.04 per
share), for the year ended December 31, 2020.
The Company concluded the 2021 year with cash of
$8,890,000 compared to $5,807,000 cash on hand as of December 31,
2020.
The total number of common shares outstanding
for the Company was 267,886,408 as at December 31, 2021.
CORPORATE HIGHLIGHTS DURING
& SUBSEQUENT TO FOURTH QUARTER AND FISCAL YEAR ENDED DECEMBER
31, 2021
Tigris Trial and Regulatory
Program
- SOFA Score
AmendmentOn November 29, 2021, the Company announced that
the United States Federal Food and Drug Agency (“FDA”) approved a
protocol amendment to its Tigris trial allowing for the use of
sequential organ failure assessment (“SOFA”) scoring as inclusion
criteria into the study, which should have a significantly positive
impact on enrollment.
- Patient
EnrollmentTotal of 30 patients randomized to-date out of
the 150 total to be enrolled in Tigris, with preliminary mortality
outcome data continuing to exceed expectations. Of the three
patients enrolled in early 2022, two were enrolled as a result of
the recent FDA approved protocol amendment allowing for the use of
SOFA scoring as inclusion criteria into the study.
- Tigris SitesAn
investigator meeting was held in February 2022. This meeting along
with the recent protocol amendment acceptance by the FDA has
resulted in trial sites responding by reporting renewed patient
screening activities. The Company is continuing to consider
additional clinical trial sites to allow for the replacement of low
performing sites. This would provide maximum potential from
fifteen active sites to be screening and enrolling.
- TimingThe Company
continues to focus on finalizing the Tigris trial within the
reasonably shortest timelines. Assuming there is no significant
recurrence of COVID-19 cases in the Tigris site ICUs, the Company
continues to target interim enrollment in Q4 2022, and finalizing
its Tigris trial enrollment in the first half of 2023.
- EDEN observational
studyIn March 2022, the Company launched an ancillary
observational study, EDEN, to collect data on patients with sepsis
even if ineligible for Tigris. EDEN will capture much needed
data on the full range of septic shock and its relation to organ
failure and endotoxin activity. These data will inform
subsequent discussions with the FDA on labelling for PMX as well as
to provide the medical community and the Company a better picture
of the addressable population in the U.S. for PMX.
Furthermore, patients enrolled in EDEN will also be considered for
entry into the Tigris study, which provides another tool to support
enrollment.
Dialco
- DIMI Usability
Trial The Dialco team is focused on the DIMI
usability trial to obtain FDA clearance for in home use, and
expects first patient enrollment in Q3 2022 with study duration of
approximately 18 months. The timing of the start of the DIMI
usability trial for home hemodialysis has also been impacted by the
COVID pandemic. Dialysis clinics are experiencing severe
staffing shortages as they work to accommodate current patients as
well as respond to an increase in patients with COVID related
kidney injury requiring dialysis. On January 31, 2022, the
FDA approved an amendment to the DIMI home hemodialysis study that
simplifies the protocol and allows for extended use for
patients. Management believes that the revised protocol
increases study feasibility and should improve
enrollment.
- Medical Advisory
BoardDialco formed a Medical Advisory Board
comprised of leading home hemodialysis experts, with significant
experience in clinical research, patient care and patient-centered
outcomes related to dialysis in the home. The medical
advisory board’s focus will be to support in guiding the DIMI
usability trial and continued clinical development of the DIMI
device.
- DIMI
CommercializationManagement believes the
35-patient usability trial represents a prime commercialization
opportunity to demonstrate positive real-world experience and the
versatility of DIMI amongst Dialco’s clinical trial partners, who
are also potential DIMI customers. In order to support commercial
expansion, and in anticipation to the start-up of the DIMI
usability trial, Dialco is expanding its field force for sales
training and technical support. Dialco currently has field
representatives in Ontario, as well as California, Pennsylvania,
Florida and Michigan, with recruitment initiatives underway for
further expansion.
- SAMI
Commercialization SAMI continues to be launched in Canada
and the U.S. with successful clinical evaluations ongoing in key
hemodialysis centres, as well as expansion of the commercial sales
pipeline. As hospitals are experiencing a significant shortage of
CRRT machines in COVID-19 affected ICUs, there has been increased
activity with respect to the use of SAMI in the treatment of
COVID-19 positive patients. The Company has successfully developed
remote installation, and set-up on-line training for SAMI. The
Company expects to continue to generate revenue in 2022 pursuant to
its existing commercial arrangements for SAMI machines and
disposables.
Addition to Spectral Senior
Leadership Team
On March 21, 2022, the Company announced the
appointment of Blair McInnis as Chief Financial Officer (effective
April 4, 2022). Mr. McInnis brings over 15 years of corporate
finance and financial reporting experience. Most recently, he
served as Vice President Finance at SMTC Corporation, a provider of
global electronics manufacturing services with annualized revenues
in excess of $450 million, where he managed financial reporting,
budgeting, treasury management and forecasting for the
organization. During his tenure, he helped oversee the
financial aspects of the acquisition and privatization of the
Company by H.I.G. Capital, a leading global private equity firm,
prior to which, SMTC was listed on
Nasdaq.
U.S. Listing
Update
Management and the Board believe a senior U.S.
listing aligns with the goals of the business and its stakeholders,
and the Company continues to prepare for a potential listing on a
senior U.S. exchange.
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™ (“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™), 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
340,000 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:
Chris Seto |
Ali Mahdavi |
David Waldman/Natalya Rudman |
CEO |
Capital Markets & Investor
Relations |
US Investor Relations |
Spectral Medical Inc. |
Spinnaker Capital Markets
Inc. |
Crescendo Communications,
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. |
Consolidated Statements of Financial Position |
|
(in thousands of Canadian dollars) |
|
December 31, 2021 |
|
December 31, 2020 |
|
|
$ |
|
$ |
|
|
|
|
Assets |
|
|
Current
assets |
|
|
Cash |
8,890 |
|
5,807 |
|
Trade and other
receivables |
205 |
|
260 |
|
Inventories |
293 |
|
348 |
|
Prepayments and other
assets |
875 |
|
389 |
|
|
10,263 |
|
6,804 |
|
Non-current
assets |
|
|
Right-of-use-asset |
532 |
|
625 |
|
Property and equipment |
532 |
|
488 |
|
Intangible asset |
228 |
|
246 |
|
Total assets |
11,555 |
|
8,163 |
|
|
|
|
Liabilities |
|
|
Current
liabilities |
|
|
Trade and other payables |
1,522 |
|
2,141 |
|
Current portion of contract
liabilities |
689 |
|
676 |
|
Current
portion of lease liability |
92 |
|
85 |
|
|
2,303 |
|
2,902 |
|
Non-current
liability |
|
|
Lease liability |
490 |
|
582 |
|
Non-current portion of contract liabilities |
4,679 |
|
5,348 |
|
Total
liabilities |
7,472 |
|
8,832 |
|
|
|
|
Shareholders’ equity
(deficiency) |
|
|
Share capital |
84,357 |
|
71,870 |
|
Contributed surplus |
7,985 |
|
7,981 |
|
Share-based compensation |
7,984 |
|
6,771 |
|
Warrants |
2,251 |
|
2,418 |
|
Deficit |
(98,494 |
) |
(89,709 |
) |
Total shareholders’
equity (deficiency) |
4,083 |
|
(669 |
) |
|
|
|
Total liabilities and shareholders’ equity
(deficiency) |
11,555 |
|
8,163 |
|
Spectral Medical Inc. |
Consolidated Statements of Loss and Comprehensive Loss |
For the years ended December 31, 2021 and 2020 |
|
(in thousands of Canadian dollars, except for share and per share
data) |
|
2021 |
|
2020 |
|
|
$ |
|
$ |
|
|
|
|
|
|
Revenue |
2,052 |
|
2,101 |
|
|
|
|
Expenses |
|
|
Changes in inventories of
finished goods and work-in-process |
286 |
|
127 |
|
Raw materials and consumables
used |
546 |
|
501 |
|
Salaries and benefits |
5,163 |
|
4,750 |
|
Consulting and professional
fees |
2,707 |
|
4,064 |
|
Regulatory and investor
relations |
612 |
|
541 |
|
Travel and entertainment |
270 |
|
146 |
|
Facilities and
communication |
293 |
|
361 |
|
Insurance |
389 |
|
248 |
|
Depreciation and
amortization |
294 |
|
304 |
|
Interest expense on lease
liability |
28 |
|
32 |
|
Foreign exchange loss
(gain) |
58 |
|
(7 |
) |
Other expense |
93 |
|
148 |
|
Write down of property and
equipment |
181 |
|
- |
|
Gain on
disposal of property and equipment |
(83 |
) |
(16 |
) |
|
10,837 |
|
11,199 |
|
|
|
|
Loss and comprehensive loss for the year |
(8,785 |
) |
(9,098 |
) |
|
|
|
Basic and diluted loss per common share |
(0.03 |
) |
(0.04 |
) |
|
|
|
Weighted average number of common shares outstanding –
basic and diluted |
252,464,462 |
|
232,502,463 |
|
Spectral Medical Inc. |
Consolidated Statements of Changes in Shareholders’ (Deficiency)
Equity |
For the years ended December 31, 2021 and 2020 |
|
(in thousands of Canadian dollars) |
|
Issued capital |
Contributed surplus |
Share-based compensation |
|
Warrants |
|
Deficit |
|
Total Shareholders’ (deficiency) 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 |
|
- |
|
4,314 |
|
Share options exercised |
1,279,062 |
772 |
- |
(292 |
) |
- |
|
- |
|
480 |
|
Warrants exercised |
1,100,000 |
735 |
- |
- |
|
(240 |
) |
- |
|
495 |
|
Loss and comprehensive loss
for the year |
- |
- |
- |
- |
|
- |
|
(9,098 |
) |
(9,098 |
) |
Share-based compensation |
- |
- |
- |
880 |
|
- |
|
- |
|
880 |
|
Balance, December 31, 2020 |
236,755,745 |
71,870 |
7,981 |
6,771 |
|
2,418 |
|
(89,709 |
) |
(669 |
) |
Bought deal offering |
23,530,000 |
7,406 |
- |
- |
|
1,464 |
|
- |
|
8,870 |
|
Share options exercised |
143,333 |
98 |
- |
(46 |
) |
|
|
- |
|
52 |
|
Warrants exercised |
7,457,330 |
4,983 |
- |
- |
|
(1,627 |
) |
- |
|
3,356 |
|
Warrants expired |
- |
- |
4 |
- |
|
(4 |
) |
- |
|
- |
|
Loss and comprehensive loss
for the year |
- |
- |
- |
- |
|
- |
|
(8,785 |
) |
(8,785 |
) |
Share-based compensation |
- |
- |
- |
1,259 |
|
- |
|
- |
|
1,259 |
|
Balance, December 31, 2021 |
267,886,408 |
84,357 |
7,985 |
7,984 |
|
2,251 |
|
(98,494 |
) |
4,083 |
|
Spectral Medical Inc. |
Consolidated Statements of Cash Flows |
For the years ended December 31, 2021 and 2020 |
|
(in thousands of Canadian dollars) |
|
2021 |
|
2020 |
|
|
$ |
|
$ |
|
Cash flow provided by
(used in) |
|
|
|
|
|
Operating
activities |
|
|
Loss for the year |
(8,785 |
) |
(9,098 |
) |
Adjustments for: |
|
|
Depreciation on right-of-use asset |
93 |
|
94 |
|
Depreciation on property and equipment |
183 |
|
193 |
|
Amortization of intangible asset |
18 |
|
17 |
|
Interest expense on lease liability |
28 |
|
32 |
|
Unrealized foreign exchange loss on cash |
56 |
|
187 |
|
Share-based compensation |
1,259 |
|
880 |
|
Write down of expired consumables |
106 |
|
- |
|
Write down of property and equipment |
181 |
|
- |
|
Gain on disposal of property and equipment |
(83 |
) |
(16 |
) |
Changes in items of working
capital: |
|
|
Trade and other receivables |
55 |
|
11 |
|
Inventories |
(51 |
) |
(72 |
) |
Prepayments and other assets |
(486 |
) |
(234 |
) |
Contract asset |
- |
|
519 |
|
Trade and other payables |
(619 |
) |
1,139 |
|
Contract liabilities |
(656 |
) |
6,024 |
|
Net cash used in operating activities |
(8,701 |
) |
(324 |
) |
|
|
|
Investing
activities |
|
|
Proceeds on disposal of
property and equipment |
158 |
|
18 |
|
Property and equipment
expenditures |
(483 |
) |
(315 |
) |
Net cash used in investing activities |
(325 |
) |
(297 |
) |
|
|
|
Financing
activities |
|
|
Proceeds from financing |
10,000 |
|
5,100 |
|
Transaction costs paid |
(1,130 |
) |
(786 |
) |
Lease liability payments |
(113 |
) |
(109 |
) |
Share options exercised |
52 |
|
480 |
|
Warrants exercised |
3,356 |
|
495 |
|
Net cash provided by financing activities |
12,165 |
|
5,180 |
|
|
|
|
Increase in cash |
3,139 |
|
4,559 |
|
Effects of exchange rate
changes on cash |
(56 |
) |
(187 |
) |
Cash,
beginning of year |
5,807 |
|
1,435 |
|
Cash, end of year |
8,890 |
|
5,807 |
|
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