American Marconi Wireless News - MedMira Reports Second Quarter Results FY2025

Corporate update

In Q2 FY2025, MedMira has received the Health Canada approval of its Multiplo^® Rapid TP/HIV Test (Multiplo^® TP/HIV) and Reveal^® Rapid HIV Test. In addition, the Company continued its regulatory work in Canada on two new products and is in the final stages for its clinical trials for the Reveal® G4 HIV-1/2 rapid test CLIA-waiver. Furthermore, the Company signed additional distribution agreements in Canada and the USA to expand its market reach in North America.

Major milestones

On the 24^th of December 2024, MedMira received the Medical Device License for its Multiplo^® TP/HIV for professional use. Subsequent to this approval, the Company received in January 2025, the Medical Device License for its latest generation of the Reveal® Rapid HIV Test. With these approvals, the Company was able to launch the products in January 2025 and work directly with its exclusive Canadian distributor Trimedic Inc. Currently, the Company is awaiting the regulatory clearance of its Reveal^® TP (Syphilis) Antibody Test from the regulatory body. At the time this approval has been received, the Company is able offer the only Health Canada approved single syphilis antibody rapid test in Canada. As a result, MedMira is able to provide a highly flexible product offering that allows customers to choose which test they prefer and with it increases testing options and market share. Given the substantial demand for affordable and high-quality testing solutions, the Company anticipates a higher-than-expected revenue growth in the Canadian market over the coming financial quarters.

In Q2 FY2025, the Company in partnership with REACH Nexus applied for the ITA (investigational testing authorization) for non-professional use and home testing application for its Multiplo^® TP/HIV. This would allow the Company to be the first TP/HIV home test in Canada and reach markets and customers beyond the traditional healthcare setting. At this stage, the Company is awaiting the green light by the regulators to commence the clinical trials in three provinces.

During Q2 FY2025, MedMira in partnership with REACH Nexus at St. Michael's Hospital's MAP Centre for Urban Health Solutions, and fully funded by the Canadian Institute of Health Research (CIHR), continued its regulatory work on its unique Multiplo^® Complete Syphilis (TP/nTP) Antibody Test (Multiplo^® TP/nTP). In December 2024, the Company received the ITA (investigational testing authorization) from Health Canada and started clinical trials.

In Q2 FY2025, the Company has made significant progress with its clinical trials in the United States for the US FDA CLIA-waiver of its FDA approved Reveal^® G4 HIV-1/2 rapid test. During the financial quarter, the Company generated over 1,000 patients' data points and with it has reached a significant step forward in obtaining the clinical trial data to achieve the US FDA CLIA-waiver. As a result of the important progress with the clinical trials, the Company recorded higher expenses in its General and Administrative Costs. This increase in costs is in direct relation to the positive progress made with the clinical trials and have been an expected investment by the Company to gain access to the CLIA-waiver HIV rapid testing market.

Profit and Loss Highlights

• Revenue: The Company recorded revenues in Q2 FY2025 of $69,001 compared to Q1 FY2025 $61,723 and $148,696 in the same period last year.

• Gross Profit: The Company recorded a gross profit in Q2 FY2025 of $45,643 compared to $52,778 in Q1 FY2025 and $68,137 in the same period last year.

• Operating expenses: The Company recorded for this quarter operating expenses of $1,141,481 compared to $1,111,283 in Q1 FY2025 and $579,374 in the same period last year.

• Net loss: The Company recorded a net loss in Q2 FY2025 of $1,199,918 compared to a net loss of $590,789 for the quarter last year.

Balance Sheet Highlights

• Assets: The Company recorded decrease of its assets by $793,437 between Q1 FY2025 and Q2 FY2025 which was mainly due to the cash required to pay the expenses for the clinical trials.

• Liabilities: The Company's liabilities increased by $406,480 between Q1 FY2025 and Q2 FY2025. The Company's current liabilities increased by $454,163 which was mainly due to an increase in accounts payable and accrued liabilities.

• Loans in default decreased by $3,761 due to the fluctuations in the United States Dollar and the Swiss Franc. All long and short terms debts are currently under negotiation to restructure terms and conditions of repayment.

• Working Capital deficit: As a result of the changes noted above, the Company recorded a higher working capital deficit of $1,172,705 or an increase of 6% compared to last quarter.

The Company's financial statements and management's discussion and analysis are available on the Company's profile on SEDAR at www.sedar.com. For matters of going concern, reference is made to the Auditor's Emphasis of Matter statement in the fiscal year ended 2024 Auditors Report and note 2b in the audited financial statements which are also available on SEDAR.

About MedMira

MedMira is the developer and owner of Rapid Vertical Flow (RVF)® Technology. The Company's rapid test applications built on RVF Technology provide hospitals, labs, clinics and individuals with instant diagnosis for diseases such as HIV and hepatitis C in just three easy steps. The Company's tests are sold under the Reveal®, Multiplo® and Miriad® brands in global markets. MedMira's corporate offices and manufacturing facilities are located in Halifax, Nova Scotia, Canada and the Company has a sales and customer service office located in the United States. For more information visit medmira.com. Follow us on Twitter and LinkedIn.

This news release contains forward-looking statements, which involve risk and uncertainties and reflect the Company's current expectation regarding future events including statements regarding possible approval and launch of new products, future growth, and new business opportunities. Actual events could materially differ from those projected herein and depend on a number of factors including, but not limited to, changing market conditions, successful and timely completion of clinical studies, uncertainties related to the regulatory approval process, establishment of corporate alliances and other risks detailed from time to time in the company quarterly filings.

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.

MedMira Contacts:

Markus Meile, CFO
Tel: 902-450-1588
Email: [email protected]

SOURCE: MedMira, Inc.

View the original press release on ACCESS Newswire

Ch.Havering--AMWN