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SQI Diagnostics Reports Fourth Quarter and Fiscal 2020 Results

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TORONTO, Jan. 27, 2021 /PRNewswire/ - 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 fourth quarter and fiscal year ended September 30, 2020.

Q4 2020 Financial Highlights

  • Sales were $0.3M, compared to $0.6M in Q4 2019 due to a combination of the absence of platform sales in the current quarter and the negative impacts of COVID-19 on the business and operations of the Company, as one of our customers temporarily suspended operations, which adversely impacted kit sales, lower service revenue due to the delay of a project with a major customer

  • Gross profit was $0.2M, compared to $0.4M in Q4 2019 due to lower service revenue

  • SG&A expense was $1.8M, compared to $0.8M in Q4 2019 due primarily to higher stock-based compensation

  • R&D expense was $1.1M, compared to $1.7M in Q4 2019 due to the benefits of the Canada Emergency Wage Subsidy ("CEWS") program

  • Net loss was $2.8M or ($0.01) per share, compared to $2.8M or ($0.01) per share in Q4 2019

  • Cash and investments were $2.6M as of Sep 30, 2020

  • Net working capital was $2.2M as of Sep 30, 2020 compared to ($0.2M) at Sep 30 2019

Fiscal 2020 Financial Highlights

  • Sales were $1.0M, compared to $1.8M in FY 2019 due to a combination of the loss of a major customer and the negative impacts of COVID-19 on the business and operations of the Company, as one of our customers temporarily suspended operations, which adversely impacted kit sales

  • Gross profit was $0.8M, compared to $1.3M in FY 2019 due to lower service revenue and kit sales

  • SG&A expense was $4.1M, compared to $3.1M in FY 2019 due to higher professional fees and stock-based compensation

  • R&D expense was $4.6M, compared to $5.0M in FY 2019 due to the benefits of the CEWS

  • Net loss was $8.6M or ($0.03) per share, compared to $8.0M or ($0.04) per share in FY 2019

Corporate Highlights during the Quarter:

  • Mr. Robert L. Chioini appointed as Chief Executive Officer

  • Patient enrollment completed for RALI-Dx clinical trial in partnership with University Health Network ("UHN") Hospitals

  • Established SQI US, Inc. to facilitate broader commercial activities in the United States

  • Completed $3.0 million dollar funding via warrant exercise by Company insiders

Mr. Robert L. Chioini, Chief Executive Officer of SQI stated, "During the last several months we have leveraged our existing technology and research platform and have made significant progress to position SQI to address the need for innovative diagnostic testing created by the COVID-19 pandemic, and beyond. Our focus is on completing the clinical development and regulatory submissions for our COVID-19 antibody and severity triage tests and expanding our manufacturing and testing footprint to maximize commercialization efforts. Simultaneously, we are enhancing our clinical and regulatory team to complete clinical validation of our TORdx™ LUNG Test to be filed timely to the FDA, while implementing an ecommerce platform to market approved healthcare tests directly to consumers." Mr. Chioini further stated, "We feel strongly that SQI's unique strategy of merging innovative diagnostics with differentiated health management services will enable us to provide comprehensive support for health care professionals, patients and consumers across the globe."

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 COVID-19 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.

SQI is fast-tracking the development of three COVID-19 diagnostic tests: a direct-to-consumer COVID-19 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 should be admitted to the hospital 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 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 TORdxLung 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 the University Health Network (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 organizations 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-dxSeverity Triage Test and its COVID-19 RALI-fastSeverity 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.