TORONTO, March 1, 2021 /CNW/ - SQI Diagnostics Inc. (TSXV:
SQD) (OTCQB: SQIDF), a precision medicine company that discovers,
develops and commercializes innovative rapid diagnostic testing for
healthcare professionals, patients and consumers worldwide, today
reported its financial and operational results for the first
quarter of fiscal year 2021, ended December
31, 2020.
Q1 2021 Financial Highlights
- Sales were $0.2M in Q1 2021,
compared to $0.2M in Q1 2020.
- Gross profit was $0.1M in Q1
2021, compared to $0.2M in Q1 2020
due to lower sales.
- SG&A expense was $1.9M in Q1
2021, compared to $0.7M in Q1 2020
due primarily to higher stock-based compensation and professional
and consulting fees.
- R&D expense was $1.8M in Q1
2021, compared to $1.3M in Q1 2020
due to an increase in clinical development activity.
- Net loss was $3.7M or
($0.01) per share in Q1 2021,
compared to $2.0M or ($0.01) per share in Q1 2020.
- Cash and investments were $5.1M
December 31, 2020 compared to
$1.5M December
31, 2019.
- Net working capital was $3.5M
December 31, 2020 compared to
($2.1M) December 31, 2019.
Corporate Highlights during the Quarter:
- Initiated clinical study for the Company's direct-to-consumer
COVID-19 HOME Antibody Test.
- Completed $4.0 million dollar
funding via warrant exercise.
Mr. Robert L. Chioini, Chief
Executive Officer of SQI stated, "We had a very productive quarter.
We made solid progress on the clinical development of our unique
COVID-19 tests and we strengthened our balance sheet with
$4 million of gross proceeds from the
exercise of warrants. Going forward, we anticipate realizing
further funding via the exercise of Company warrants and greater
advancement on our clinical development and commercialization
efforts."
About SQI Diagnostics
SQI Diagnostics, Inc. is a precision medicine company that
discovers, develops and commercializes innovative rapid diagnostic
testing for healthcare providers, patients and consumers worldwide.
The Company's proprietary advanced diagnostics target organ
transplant, autoimmune disease and serological testing, which
include the developmental direct-to-consumer COVID-19 HOME Antibody
Test, the RALI-dx™ COVID-19 Severity Triage Test and the
COVID-19 RALI-fast™ Severity Triage Point-of-Care
(POC) Test. SQI's rapid diagnostic tests are intended to be sold to
healthcare professionals so that patients can get accurate
results and fast effective treatment, and direct-to-consumers so
that individuals can be empowered to improve their health outcomes
from the comfort of home.
Under serological testing, SQI is fast-tracking the development
of three Covid-19 diagnostic tests: a direct-to-consumer Antibody
Test and two Covid-19 Severity Triage tests. The COVID-19 HOME
Antibody Test identifies the presence of IgM, IgA and IgG
antibodies of SARS-CoV-2 in individuals suspected to have been
infected with COVID-19 and asymptomatic individuals wanting to know
if they have been exposed. The test is > 99% accurate with
results delivered in 24-48 hours. The Company currently expects to
apply to the U.S. Food and Drug Administration ("FDA") for
Emergency Use Authorization ("EUA") for its Covid-19 HOME
Antibody Test in the second quarter of calendar year 2021. Should
the COVID-19 HOME Antibody Test receive regulatory approval, the
test is expected to be available direct-to-consumer which would
allow individuals to avoid travelling to a clinic or hospital to be
tested for the presence of the SARS-CoV-2 antibody.
The RALI-dx™ COVID-19 Severity Triage Test and the
RALI-fast™ COVID-19 Severity Triage POC Test each
help clinicians identify which patients with SARS-CoV-2 will have a
severe inflammatory response and require hospital admission or not.
Both tests measure the critical biomarker IL-6 which plays a key
role in the cytokine storm phase of COVID-19. The RALI-dx™ delivers
results from the lab in about 50 minutes while the
RALI-fast™ delivers results at the patient's
point-of-care in about 15 minutes. The Company currently expects to
apply for EUA to the FDA and for an interim order with Health
Canada for both tests in the first and second quarters of calendar
year 2021, respectively.
Under organ transplant, SQI is pioneering the development of an
advanced diagnostic test that increases the chance of successful
lung transplant by assessing the health of the donor organ prior to
transplant surgery. The Company's developmental
TORdx™ Lung Test can detect inflammation at the
molecular level to assess the health of the donor lung, enabling
surgeons to transplant healthy lungs which otherwise would have
been rejected; there is currently no other such test. SQI has
partnered clinical development with UHN Hospitals, one of the
largest health and medical research organizations in North America. Upon regulatory approval of the
TORdx™ Lung Test, clinical development is planned
for diagnostic tests designed to increase the chance of successful
kidney and liver transplant.
Under autoimmune disease testing, SQI has a direct-to-consumer
Celiac Disease and a Rheumatoid Arthritis (RA) Test that enable
people to screen for the diseases from the comfort of their home.
The direct-to-consumer RA Test can help identify and confirm RA
symptoms for timely care and treatment. The direct-to-consumer
Celiac Test confirms disease and validates the effectiveness of
dietary and lifestyle changes to confirm the autoimmune response is
improving.
The Company is not making any express or implied claims that its
products can eliminate, cure or contain Covid-19 (or SARS-2
Coronavirus) at this time. For its research and development,
the Company is collaborating with UHN Hospitals, one of the largest
health and medical research organization in North America.
For more information, please visit www.sqidiagnostics.com.
FORWARD-LOOKING INFORMATION
This press release contains certain words and statements,
which may constitute "forward-looking statements" within the
meaning of applicable securities laws. Such
forward-looking statements may be identified by words such as
"anticipates", "plans", "proposes", "estimates", "intends",
"expects", "believes", "may" and "will". The forward-looking
statements reflect the current views of the Company
with respect to future events and are subject to certain risks and
uncertainties detailed in the Company's ongoing filings with the
securities regulatory authorities, available to the public at
www.sedar.com. Such statements are subject to numerous important
factors, risks and uncertainties, many of which are beyond the
company's control, that may cause actual events or results to
differ materially from the company's current expectations.
Management's expectations and therefore any forward-looking
statements in this press release could be affected by risks and
uncertainties relating to a number of factors, including, but not
limited to, the following: the development and viability the
Company's COVID-19 HOME Antibody Test, its COVID-19
RALI-dx™ Severity Triage Test and its COVID-19
RALI-fast™ Severity Triage Point-of-Care (POC) Test, the
suitability of such tests for advanced clinical testing, including
human trials, the content and timing of decisions
made by the FDA relating to the use and commercialization of such
tests, the timing and costs involved in establishing the
commercialization of the tests, the impact that the ongoing
COVID-19 pandemic may have on the company's business, including the
expected development, manufacturing, regulatory and
commercialization timelines relating to the aforementioned
COVID-19-related tests. Readers are cautioned not to place undue
reliance on these forward-looking statements. The Company
undertakes no obligation to publicly update or revise any
forward-looking statements either as a result of new information,
future events or otherwise, except as required by applicable
securities laws.
Neither TSX Venture Exchange nor its Regulation Services
Provider (as that term is defined in the policies of the TSX
Venture Exchange) accepts responsibility for the adequacy or
accuracy of this release.
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SOURCE SQI Diagnostics Inc.