Mainz BioMed N.V., corporate

Mainz BioMed N.V.,

07.09.2022 - 09:04:49

Mainz Biomed Reports First Half 2022 Financial Results

Mainz Biomed N.V. ?Condensed Consolidated Statements of Financial Position ?June 30, 2022 and December 31, 2021 ?(unaudited) ? ? ? ? ? ? ? ? ? ? ? ? ?June 30, ? ?December 31, ? ? ? ? ? ?2022 ? ?2021 ? ? ?ASSETS ? ? ? ? ? ? ? ?Current assets ? ? ? ? ? ? ? ?Cash and cash equivalents ? ? ?$??? 26.006.609 ? ?$????? 8.727.542 ? ? ?Trade and other receivables, net ? ? ??????????? 332.918 ? ??????????? 111.842 ? ? ?Other assets ? ? ??????????? 458.784 ? ??????????? 769.825 ? ? ?TOTAL CURRENT ASSETS ? ? ?????? 26.798.311 ? ???????? 9.609.209 ? ? ?? ? ? ? ? ? ? ? ?Fixed and other assets ? ? ??????????? 817.041 ? ??????????? 431.586 ? ? ? ? ? ? ? ? ? ? ?TOTAL ASSETS ? ? ?$??? 27.615.352 ? ?$??? 10.040.795 ? ? ? ? ? ? ? ? ? ? ?LIABILITIES AND SHAREHOLDERS' EQUITY (DEFICIT) ? ? ? ? ? ? ? ?Current liabilities ? ? ? ? ? ? ? ?Accounts payable and other accrued liabilities ? ? ?$????? 1.205.788 ? ?$???????? 784.786 ? ? ?Current maturities of long-term debt ? ? ???????? 1.108.658 ? ??????????? 278.183 ? ? ?Other current liabilities ? ? ??????????? 159.116 ? ??????????? 288.786 ? ? ?TOTAL CURRENT LIABILITIES ? ? ???????? 2.473.562 ? ???????? 1.351.755 ? ? ? ? ? ? ? ? ? ? ?Long term debt ? ? ??????????? 894.832 ? ???????? 1.940.119 ? ? ?Other liabilities ? ? ??????????? 475.148 ? ??????????? 387.766 ? ? ?TOTAL LIABILITIES ? ? ???????? 3.843.542 ? ???????? 3.679.640 ? ? ? ? ? ? ? ? ? ? ?TOTAL SHAREHOLDERS' EQUITY (DEFICIT) ? ? ?????? 23.771.810 ? ???????? 6.361.155 ? ? ? ? ? ? ? ? ? ? ?TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY (DEFICIT) ? ? ?$??? 27.615.352 ? ?$??? 10.040.795 ? ? ? ? ? ? ? ? ? ?Mainz Biomed N.V. ?Condensed? Consolidated Statements of Profit and Loss and Comprehensive Loss ?For the Six Months Ended June 30, 2022 and 2021 ?(unaudited) ? ? ? ? ? ? ? ? ? ? ? ? ?Six months ended June 30, ? ? ? ? ? ?2022 ? ?2021 ? ? ? ? ? ? ? ? ? ? ?REVENUE ? ? ? ? ? ? ? ?ColoAlert revenue ? ? ?$???????? 238.255 ? ?$???????? 104.851 ? ? ?Other revenue ? ? ??????????????? 1.550 ? ??????????? 312.460 ? ? ?TOTAL REVENUE ? ? ??????????? 239.805 ? ??????????? 417.311 ? ? ?Cost of Revenue ? ? ??????????? 119.005 ? ????????????? 64.772 ? ? ?GROSS PROFIT ? ? ??????????? 120.800 ? ??????????? 352.539 ? ? ?OPERATING EXPENSES ? ? ? ? ? ? ? ?Research and Development ? ? ??????????? 911.716 ? ??????????? 206.146 ? ? ?Sales and Marketing ? ? ???????? 2.520.496 ? ??????????? 150.335 ? ? ?General and Administration ? ? ???????? 9.268.054 ? ??????????? 250.692 ? ? ?TOTAL OPERATING EXPENSES ? ? ?????? 12.700.266 ? ??????????? 607.173 ? ? ?OPERATING LOSS ? ? ???? (12.579.466) ? ????????? (254.634) ? ? ?Other Expenses ? ? ????????????? 22.981 ? ??????????????? 7.087 ? ? ?NET LOSS ? ? ?$? (12.602.447) ? ?$?????? (261.721) ? ? ?TOTAL COMPREHENSIVE LOSS ? ? ?$? (12.519.804) ? ?$?????? (178.758) ? ? ?BASIC AND DILUTE LOSS PER COMMON SHARE ? ? ?$???????????? (0,91) ? ?$???????????? (0,05) ? ? WEIGHTED AVERAGE NUMBER OF ORDINARY SHARES OUTSTANDING ? ? ?????? 13.821.914 ? ???????? 5.607.243 ?

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About ColoAlert

ColoAlert detects colorectal cancer (CRC) via a simple-to-administer test with a sensitivity and specificity nearly as high as the invasive colonoscopy*. The test utilizes proprietary methods to analyze cell DNA for specific tumor markers combined with the fecal immunochemical test (FIT) and is designed to detect tumor DNA and CRC cases in their earliest stages. The product is CE-IVDR marked (complying with EU safety, health and environmental requirements). The product is commercially available in a selection of countries in the European Union and in the United Arab Emirates. Mainz Biomed currently distributes ColoAlert through a number of clinical affiliates. Once approved in the U.S., the Company?s commercial strategy is to establish scalable distribution through a collaborative partner program with regional and national laboratory service providers across the country.

*Dollinger MM et al. (2018)

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About Colorectal Cancer

Colorectal cancer (CRC) is the second most lethal cancer in the U.S. and Europe, but also the most preventable with early detection providing survival rates above 90%. Annual testing costs per patient are minimal, especially when compared to late-stage treatments of CRC which cost patients an average of $38,469 per year. The American Cancer Society estimated that in 2021 there were approximately 149,500 new cases of colon and rectal cancer in the U.S. with 52,980 resulting in death.? Recent FDA decisions suggest that screening with stool DNA tests such as ColoAlert in the US should be conducted once every three years starting at age 45. Currently there are 112 million Americans aged 50+, a total that is expected to increase to 157 million within 10 years. Appropriately testing these US-based 50+ populations every three years as prescribed equates to a US market opportunity of approximately $3.7 Billion per year.

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About Pancreatic Cancer

Each year, about 466,000 lives are taken globally, and it?s the seventh leading cause of cancer-related death worldwide.1 It has one of the lowest survival rates of any cancer, with typically late detection and poor outcomes with standard of care treatment(s). The 5-year overall survival rate is approximately 11% in the U.S.2 and 9% globally.3 However, if diagnosis occurs in the early stages of the disease, the survival rate is significantly higher, hence the rationale behind launching the PancAlert initiative

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About Mainz Biomed N.V.

Mainz Biomed develops market-ready molecular genetic diagnostic solutions for life-threatening conditions. The Company?s flagship product is ColoAlert, an accurate, non-invasive, and easy-to-use early detection diagnostic test for colorectal cancer. ColoAlert is currently marketed across Europe and in the United Arab Emirates with the intention of beginning its pivotal FDA clinical study in 2022 for U.S. regulatory approval. Mainz Biomed?s product candidate portfolio also includes PancAlert, an early-stage pancreatic cancer screening test based on Real-Time Polymerase Chain Reaction-based (PCR) multiplex detection of molecular-genetic biomarkers in stool samples.

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For more information, please visit?www.mainzbiomed.com

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For media enquiries, please contact press@mainzbiomed.com

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For investor enquiries, please contact ir@mainzbiomed.com

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Forward-Looking Statements

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Certain statements made in this press release are ?forward-looking statements? within the meaning of the ?safe harbor? provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words such as ?anticipate?, ?believe?, ?expect?, ?estimate?, ?plan?, ?outlook?, and ?project? and other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements reflect the current analysis of existing information and are subject to various risks and uncertainties. As a result, caution must be exercised in relying on forward-looking statements. Due to known and unknown risks, actual results may differ materially from the Company?s expectations or projections. The following factors, among others, could cause actual results to differ materially from those described in these forward-looking statements: (i) the failure to meet projected development and related targets; (ii) changes in applicable laws or regulations; (iii) the effect of the COVID-19 pandemic on the Company and its current or intended markets; and (iv) other risks and uncertainties described herein, as well as those risks and uncertainties discussed from time to time in other reports and other public filings with the Securities and Exchange Commission (the ?SEC?) by the Company. Additional information concerning these and other factors that may impact the Company?s expectations and projections can be found in its initial filings with the SEC, including its registration statement on Form F-1 filed on January 21, 2022. The Company?s SEC filings are available publicly on the SEC?s website at www.sec.gov. Any forward-looking statement made by us in this press release is based only on information currently available to Mainz Biomed and speaks only as of the date on which it is made. Mainz Biomed undertakes no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise, except as required by law.

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Language: English Company: Mainz BioMed N.V. Robert-Koch-Strasse 50 55129 Mainz

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