Mainz Biomed Provides Full Year 2022 Financial Results
ColoAlert Revenue Increases 130% Year over Year
Year End Cash Balance of $17.1 Million
BERKELEY, Calif. and MAINZ, Germany, April 10, 2023 (GLOBE NEWSWIRE) -- Mainz Biomed N.V. (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”), a molecular genetics diagnostic company specializing in the early detection of cancer, announced today financial results for the fiscal year ended December 31, 2022.
“Throughout the year we operated in a position of financial strength enabling us to achieve meaningful growth across commercial, operational and product development fronts,” commented Guido Baechler, Chief Executive Officer of Mainz Biomed. “Heading into fiscal 2023, we have a defined set of priorities intended to facilitate our goal of becoming the leading developer of premier cancer-focused early detection and disease prevention molecular diagnostics.”
Key Highlights and 2022 Accomplishments
- Expanded international commercial activities for ColoAlert, the Company’s highly efficacious and easy-to-use detection test for colorectal cancer (CRC), including five new lab partners in Germany and Italy
- Acquired exclusive rights to five novel mRNA biomarkers which have demonstrated unique ability to identify advanced adenomas (curable precancerous polyps)
- Executed a USD 25.8 million (gross) follow-on offering of ordinary shares
- Initiated and commenced patient enrollment in European and U.S. studies (ColoFuture/eAArly DETECT) evaluating the integration of Mainz’s portfolio of proprietary and novel gene expression (mRNA) biomarkers into ColoAlert; potential to identify advanced adenomas, a type of pre-cancerous polyp often attributed to CRC; Results from both studies expected in 2023
- Initiated ReconAAsense, U.S. Pivotal Clinical Study with Company’s CRC screening test; anticipate commencing patient enrollment in the second half of 2023
- Enhanced leadership team with appointments to Board of Directors and Company executives to lead commercial and product development groups, with former executives and senior management from Roche, Abbott, Luminex, and Qiagen; expanded Medical Advisory Board of global leaders in molecular diagnostic development
- Achieved multiple preclinical milestones supporting the continued development of PancAlert, a potential first-in-class screening test for pancreatic cancer
Consolidated Statements of Financial Position
December 31, | December 31, | |||||||||
2022 | 2021 | |||||||||
ASSETS | ||||||||||
Current Assets | ||||||||||
Cash | $ | 17,141,775 | $ | 8,727,542 | ||||||
Trade and other receivables, net | 259,138 | 111,842 | ||||||||
Inventories | 175,469 | - | ||||||||
Prepaid expenses | 801,959 | 769,825 | ||||||||
Total Current Assets | 18,378,341 | 9,609,209 | ||||||||
Property and equipment, net | 661,692 | 37,884 | ||||||||
Intangible asset | - | - | ||||||||
Right-of-use asset | 1,177,695 | 393,702 | ||||||||
Other asset | 23,275 | - | ||||||||
Total assets | $ | 20,241,003 | $ | 10,040,795 | ||||||
LIABILITIES AND SHAREHOLDERS’ EQUITY | ||||||||||
Current Liabilities | ||||||||||
Accounts payable and accrued liabilities | $ | 2,656,679 | $ | 784,786 | ||||||
Accrued payroll | 260,000 | 233,710 | ||||||||
Accounts payable – related party | - | 84,750 | ||||||||
Convertible debt | 43,057 | 45,666 | ||||||||
Convertible debt – related party | 32,181 | 32,221 | ||||||||
Loans payable | - | 22,754 | ||||||||
Loans payable – related party | - | 92,792 | ||||||||
Silent partnership | 759,168 | - | ||||||||
Silent partnership – related party | 206,167 | - | ||||||||
Lease liabilities | 285,354 | 55,076 | ||||||||
Total current liabilities | 4,242,606 | 1,351,755 | ||||||||
Silent partnerships | 687,128 | 1,463,981 | ||||||||
Silent partnerships – related party | 256,086 | 476,138 | ||||||||
Lease liabilities | 959,116 | 387,766 | ||||||||
Total Liabilities | 6,144,936 | 3,679,640 | ||||||||
Shareholders’ equity | ||||||||||
Share capital | 164,896 | 141,075 | ||||||||
Share premium | 38,831,542 | 13,126,493 | ||||||||
Reserve | 18,079,741 | 9,736,066 | ||||||||
Accumulated deficit | (43,032,294 | ) | (16,644,958 | ) | ||||||
Accumulated other comprehensive income | 52,182 | 2,479 | ||||||||
Total shareholders’ equity | 14,096,067 | 6,361,155 | ||||||||
Total liabilities and shareholders’ equity | $ | 20,241,003 | $ | 10,040,795 |
Consolidated Statements of Comprehensive Loss
Years Ended December 31, | |||||||||||
2022 | 2021 | ||||||||||
Revenue | |||||||||||
ColoAlert revenue | $ | 519,728 | $ | 226,438 | |||||||
Covid-19 and other revenue | 10,149 | 350,910 | |||||||||
Total revenue | 529,877 | 577,348 | |||||||||
Cost of revenue | 347,726 | 399,726 | |||||||||
Gross profit | 182,151 | 177,622 | |||||||||
Operating expenses: | |||||||||||
General and administrative | 17,328,942 | (a) | 8,478,017 | (a) | |||||||
Sales and marketing | 5,702,143 | 957,522 | |||||||||
Research and development | 3,660,495 | 466,689 | |||||||||
Total operating expenses | 26,691,580 | 9,902,228 | |||||||||
Loss from operations | (26,509,429 | ) | (9,724,606 | ) | |||||||
Other income (expense) | 122,093 | (1,965,492 | ) | ||||||||
Income (loss) before income tax | (26,387,336 | ) | (11,690,098 | ) | |||||||
Income taxes provision | - | - | |||||||||
Net loss | $ | (26,387,336 | ) | $ | (11,690,098 | ) | |||||
Foreign currency translation gain (loss) | 49,703 | 204,969 | |||||||||
Comprehensive loss | $ | (26,337,633 | ) | $ | (11,485,129 | ) | |||||
Basic and dilutive loss per ordinary share | $ | (1.86 | ) | $ | (1.62 | ) | |||||
Weighted average number of ordinary shares outstanding | 14,157,492 | 7,210,889 |
(a) General and administrative expenses included $9.9 million and $6.6 million of non-cash stock-based compensation, depreciation and amortization in the twelve months ended December 31, 2022 and 2021, respectively.
About ColoAlert
ColoAlert®, Mainz Biomed’s flagship product, delivers high sensitivity and specificity in a user-friendly, at-home colorectal cancer (CRC) screening kit. This non-invasive test can be indicative of tumors as determined by analyzing tumor DNA, offering better early detection than fecal occult blood tests (FOBT). Based on PCR-technology, ColoAlert detects more cases of colorectal cancer than other stool tests and allows for an earlier diagnosis (
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