SQI DIAGNOSTICS INC ORD - SQIDF STOCK NEWS

SQI Diagnostics Inc. (TSXV: SQD) (OTCQB: SQIDF) reported financial results for Q1 2022, showing sales of $0.06M, down from $0.16M in Q1 2021, mainly due to production issues and a strategic exit from the Lifesciences sector. Gross profit decreased to $0.05M from $0.1M a year prior. SG&A expenses were $1.7M, slightly down from $1.8M, while R&D expenses remained stable at $1.7M. Cash reserves totaled $3.4M. The company completed a private placement of $5.1M and acquired Precision Biomonitoring’s diagnostics business for $6.8M.

SQI Diagnostics Inc. (TSXV: SQD, OTCQB: SQIDF) released its financial results for Q4 and fiscal year ended September 30, 2021. Q4 sales dropped to $0.1M from $0.3M year-over-year due to reduced RALI-Dx™ IL-6 Severity Triage Test kit sales amid increased R&D activities. Fiscal 2021 sales were $0.9M versus $1M in 2020, with a net loss of $(2.6M) per share. Significant corporate updates included the appointment of Andrew Morris as CEO and a $6.8M acquisition of Precision Biomonitoring's COVID-19 PCR testing business. Cash position at $2.3M as of September 30, 2021.

SQI Diagnostics announced a Memorandum of Understanding (MOU) with Owlstone Medical to develop breath-based biomarkers for invasive aspergillus lung infection and lung transplant rejection. This collaboration aims to improve early diagnosis and treatment by utilizing Owlstone's Breath Biopsy platform alongside SQI's expertise in lung health diagnostics. The partnership will explore regulatory strategies and commercialization efforts, although the MOU is non-binding. This innovative approach addresses significant medical needs, especially for transplant patients with high susceptibility to fungal infections.

SQI Diagnostics Inc. congratulates the University Health Network (UHN) on winning a $24 million award from Canada's New Frontiers in Research Fund. This award supports the development of Ex Vivo Lung Perfusion (EVLP) technology, which enhances lung transplant viability by doubling the number of donor lungs used. SQI's collaboration with UHN has led to the TORdx^TMLUNG test for immunological profiling of donor lungs. The funding aims to expand EVLP technology to other organ transplants, enhancing precision diagnostics and advancing organ preservation methods.

SQI Diagnostics Inc. (SQIDF) has responded to a significant shift in FDA priorities regarding Emergency Use Authorization (EUA) for COVID-19 tests. The FDA will no longer prioritize at-home testing for COVID-19 antibody tests, which affects devices awaiting review. SQI, which has not yet submitted its EUA application, will pivot to a model where trained medical professionals collect samples. This strategy aligns with the FDA's current focus on convenient testing and aims to enhance patient experience through pain-free fingerstick sample collection in various accessible locations.

SQI Diagnostics has appointed Andrew Morris as CEO, effective September 11, 2021. Morris, who has extensive experience in diagnostics and life sciences, was previously managing partner at ATTWILL Medical Solutions and has a notable history with SQI, having served as CEO and CFO. He aims to drive growth and secure FDA approval for the HOME Antibody Test. Additionally, Morris has been granted 12,000,000 stock options with specific vesting conditions aligned with company performance.

SQI Diagnostics Inc. (TSXV: SQD; OTCQB: SQIDF) reported its Q3 2021 financial results, showing sales of $0.3M, consistent with Q3 2020. SG&A expenses increased to $1.2M, partly due to stock option recovery for the former CEO. R&D expenses rose to $2.0M, reflecting intensified efforts for FDA product approvals. The net loss was $0.7M, an improvement from $1.5M in Q3 2020. Cash and investments stood at $5.0M, up from $2.6M year-on-year. Corporate highlights included a $3.9M funding boost and progress toward FDA approval for a COVID-19 Home Antibody Test.

On July 23, 2021, SQI Diagnostics Inc. (SQIDF) announced that the FDA will not continue its review of the RALI-Dx™ IL-6 Severity Triage Test for Emergency Use Authorization (EUA). The FDA cited a high volume of EUA requests as the reason for its decision and recommended SQI to pursue a non-EUA regulatory pathway. Interim CEO Clive Beddoe expressed disappointment but remains optimistic about future submissions, including the upcoming COVID-19 HOME Antibody Test. This decision may impact SQI's market position and investor confidence amid ongoing public health needs.

SQI Diagnostics Inc. (TSXV: SQD) (OTCQB: SQIDF) has partnered with AZOVA Inc. to distribute SQI's COVID-19 HOME Antibody Test, pending FDA approval. This innovative test aims to be the most comprehensive consumer antibody test, detecting immune responses to both SARS-CoV-2 and major vaccines. With >99% accuracy, the test allows consumers to obtain results digitally within 12-48 hours. AZOVA will facilitate access to this test through its extensive network, enhancing public health amidst the ongoing pandemic.