SQI Diagnostics Reports Second Quarter 2021 Results and Announces Departure of CEO and Appointment of Interim CEO

TORONTO, May 21, 2021 /PRNewswire/ - SQI Diagnostics Inc. ("SQI" or the "Company") (TSXV: SQD) (OTCQB: SQIDF), a precision medicine company that discovers, develops and commercializes innovative rapid diagnostic testing for healthcare professionals, patients and consumers worldwide, announced today that due to the unfortunate continued travel restrictions and inability to cross the US/Canadian border since the COVID-19 pandemic began, including the inability to predict when travel restrictions will end, Mr. Robert Chioini, Chief Executive Officer, is leaving the Company to pursue other opportunities. Mr. Chioini's departure becomes effective at the close of business, however he will remain available to help the Company during its transition. SQI wishes Mr. Chioini well in his next endeavor. Mr .Chioini is also resigning as a director of the Company.

The Company also announces that Mr. Clive Beddoe has been appointed the Interim Chief Executive Officer of the Company. Mr. Beddoe currently serves as Chair of the Board of Directors of the Company and has served as a director since April 2015. The Company will provide an update in due course regarding the appointment of a new full-time Chief Executive Officer.

The Company also announced today its second quarter results.

Q2 2021 Financial Highlights

• Sales were $0.3M, compared to $0.3M in Q2, 2020
• Gross profit was $0.3M, compared to $0.2M in Q2, 2020; the increase is due to an increase in higher margin sales
• SG&A expense was $1.6M, compared to $0.9M in Q2, 2020; the increase is due primarily to higher stock-based compensation
• Interest expense was $0.1M compared to $0.2M in Q2, 2020; the decrease is due to a lower average debt balance in 2021
• R&D expense was $2.1M compared to $1.5M in Q2, 2020; the increase is due to higher clinical & regulatory costs for the Company's COVID-19 testing products
• Net loss was $3.6M or ($0.01) per share, compared to $2.3M or ($0.01) per share in Q2, 2020
• Cash and investments were $3.8M as of March 31, 2021
• Net working capital was $2.9M compared to $2.2M as of March 31, 2020

Corporate Highlights during the Quarter:

• Submitted EUA with the FDA for the Company's RALI-Dx^™ IL-6 Severity Triage Test
• Realized net proceeds of $2.25 million in funding via exercise of warrants and share options

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^™ IL-6 Severity Triage Test and the COVID-19 RALI-fast^™ IL-6 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 its COVID-19 diagnostic tests: a direct-to-consumer COVID-19 HOME Antibody Test and two COVID-19 IL-6 Severity Triage Tests. The COVID-19 HOME Antibody Test identifies the semi-quantitative presence of IgM, IgA and IgG antibodies of SARS-CoV-2 in individuals who have been infected with COVID-19, individuals who have been vaccinated or 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^™ IL-6 Severity Triage Test and the RALI-fast^™ IL-6 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 to aid in determining the risk of intubation with mechanical ventilation. Both tests measure the critical biomarker IL-6 which plays a key role in the cytokine storm phase of COVID-19. The RALI-Dx^™ IL-6 Severity Triage Test delivers results from the lab in about 50 minutes while the RALI-fast^™ IL-6 Severity Triage POC test delivers results at the patient point-of-care in about 15 minutes.

With 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 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.

For 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. The forward-looking statements in this press release include, without limitation, statements with respect to the timing of the appointment of a new, full-time, Chief Executive Officer of the Company. 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.

SOURCE SQI Diagnostics Inc.

Related Links

www.sqidiagnostics.com