SQI Diagnostics Inc. (SQIDF) 11/15/21 Update

Based Upon Press Announcement, Insiders Spent $6m fresh money to invest at US$0.1426 per share. We feel comfortable doubling down to this “insider” price threshold.

Mon, November 8, 2021, 6:08 PM Press Announcement

In this article:

• SQI—Recently hired new CEO Andrew Morros
• Company raised $6mm $mm done by insiders
• Signed exclusive distribution deal with AZOVA
• About to file for EUA Approval on first ever Antibody Test that measures all 3 biomarkers IGG, IGA, IGM with a 99.9% accuracy
• Looking for approval 30-45 days after submission

About SQI Diagnostics:

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 traveling to a clinic or hospital to be tested for the presence of the SARS-CoV-2 antibody.

HOME Antibody Test receive regulatory approval

The test is expected to be available direct-to-consumer which would allow individuals to avoid traveling 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 helps 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.

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’s 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 a successful kidney and liver transplant.

Autoimmune disease testing

SQI has a direct-to-consumer Celiac Disease and a Rheumatoid Arthritis (RA) Test that enables people to screen for the diseases from the comfort of their homes. 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.

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 includes 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.

TORONTO, Nov. 1, 2021 /CNW/ – SQI Diagnostics Inc. (“SQI” or the “Company”) (TSXV: SQD) (OTCQB: SQIDF)

A life sciences and diagnostics company that develops and commercializes proprietary technologies and products for advanced microarray diagnostics, today announced that it has completed the first tranche of a non-brokered private placement (the “Private Placement”) of 23,726,316 units (“Units”) of the Company at a price of $0.19 per Unit for gross proceeds of approximately $4.5 million.

Each Unit consists of one common share and one common share purchase warrant. Each common share purchase warrant entitles the holder to purchase one common share at a price of $0.25 for a period of five years from the date of issuance.

Insiders of the Company, who are control persons, subscribed for an aggregate of 21,052,631 Units for gross proceeds of approximately $4 million under the Private Placement.

SQI Diagnostics Inc. Closes Second and Final Tranche of Private Placement

Mon, November 8, 2021, 6:08 PM

SQIDF

-6.78%

TORONTO, Nov. 8, 2021 /CNW/ – SQI Diagnostics Inc. (“SQI” or the “Company”) (TSXV: SQD) (OTCQB: SQIDF)

A life sciences and diagnostics company that develops and commercializes proprietary technologies and products for advanced microarray diagnostics, today announced that it has completed the second and final tranche of a non-brokered private placement (the “Private Placement”) of 3,206,579 units (“Units”) of the Company at a price of $0.19 per Unit for gross proceeds of approximately $610,000.

Each Unit consists of one common share and one common share purchase warrant. Each common share purchase warrant entitles the holder to purchase one common share at a price of $0.25 for a period of five years from the date of issuance.

The aggregate gross proceeds raised by the Company in connection with the completion of the previously announced first tranche of the Private Placement, which closed on November 1, 2021, and the second tranche of the Private Placement is approximately $5.1 million, resulting from the issuance of a total of 26,932,895 Units.

The Private Placement is subject to all necessary regulatory and stock exchange approvals. The securities issued pursuant to the second tranche of the Private Placement will be subject to a hold period expiring March 9, 2022, in accordance with applicable Canadian securities law. In connection with the Private Placement, the Company paid a finder’s fee of $7,648 in cash.

The securities described herein have not been, and will not be, registered under the United States Securities Act of 1933, as amended (the “U.S. Securities Act”) or any state securities laws and accordingly may not be offered or sold within the United States or to “U.S. persons”, as such term is defined in Regulation S promulgated under the U.S. Securities Act (“U.S. Persons”), except in compliance with the registration requirements of the U.S. Securities Act and applicable state securities requirements or pursuant to exemptions therefrom.

SQI intends to use the net proceeds of the Private Placement to fund the Company’s product commercialization and manufacturing programs, sales and marketing, and for general working capital purposes.

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.