Company Expects to Use Proceeds for Clinical Development and Commercialization Efforts
TORONTO, Feb. 10, 2021 /CNW/ – SQI Diagnostics Inc. (the “Company” or “SQI”) ( (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 announced that certain insiders of the Company, who are also control persons of the Company and collectively own, or exercise control or direction over, an aggregate of 78% of the issued and outstanding common shares (“Shares”) in the capital of the Company (the “Majority Shareholders”), have informed the Company of their intention to sell, from time to time, up to an aggregate of 15 million Shares at or around the prevailing market price of the Shares at the time of such sales, and to use the proceeds of such sales (net of commissions, taxes and other selling costs) to finance the exercise of common share purchase warrants (“Warrants”) held by such Majority Shareholders at exercise prices ranging from $0.12 to $0.21 (the “Warrant Exercise”) in order to fund the Company.
Each of the Majority Shareholders has filed a Form 45-102F1 – Notice of Intention to Distribute Securities under Section 2.8 of NI 45-102 Resale of Securities ( the “Sale Notices”) in connection with the contemplated sales of Shares to fund the Warrant Exercise. The Company has also been informed by each of the Majority Shareholders that such shareholders intend to execute the sales of Shares through a combination of private and over the market trades during the duration of the sales period contemplated in the Sale Notices, which will expire on March 11, 2021. The Majority Shareholders have informed the Company that they intend to continue to fund the Company through the exercise of Warrants from time to time with proceeds raised from the sale of Shares pursuant to future Sales Notices until their respective Warrant holdings are extinguished and $19,132,373 has been invested in the Company. There is no assurance as to the timing of the transactions contemplated in the Sales Notices nor whether any such transactions will occur.
“We are excited to move forward with this significant funding initiative for SQI”, stated Mr. Robert L. Chioini, CEO of SQI. “This strategy to exercise the Warrants is an ideal way to fund the Company while it also enables us to improve our capital structure and liquidity. We intend to use the cash proceeds from the Warrant exercises to execute our business plan, by financing clinical development and the commercialization of our innovative diagnostics. The intended Warrant exercise by the three Majority Shareholders shows their support and commitment to the SQI business strategy,” added Mr. Chioini.
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 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.
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.
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 completion of the insider sales and Warrant exercises contemplated in the Sales Notices, 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.
For further information: Chief Financial Officer, Morlan Reddock, 416.674.9500 ext. 277, firstname.lastname@example.org