BERKELEY, Calif. and MAINZ, Germany, April 09, 2024 (GLOBE NEWSWIRE) -- Mainz Biomed N.V. (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”), a leader in molecular genetics diagnostic solutions for early cancer detection, announced today financial results for the fiscal year ended December 31, 2023.
“This past fiscal year represented an important period of progress for the Company highlighted by reporting results from our groundbreaking ColoFuture and eAArly DETECT studies which demonstrated extraordinary statistical significance for colorectal cancer (CRC) detection and advanced adenomas, a type of pre-cancerous polyp which are considered precursors to colorectal cancer,” commented Guido Baechler, Chief Executive Officer of Mainz Biomed. “This outstanding outcome positions our much-anticipated ReconAAsense pivotal FDA PMA study to be optimally designed to evaluate a best-in-class self-administered CRC screening tool which if successful, will be the gold standard stool-based diagnostic for this deadly disease. As we make final preparations to initiate ReconAAsense’s patient enrollment, which remains on track to begin later this year, we will continue expanding the international commercialization of ColoAlert®, our highly efficacious and easy-to-use DNA-based detection test for CRC and advance the balance of our product development pipeline.”
Key 2023 Accomplishments and Recent Highlights
- Announced groundbreaking results from ColoFuture (Europe) and eAArly DETECT (U.S.) clinical studies evaluating the potential to include novel gene expression (mRNA) biomarkers into a next generation version of Mainz BioMed’s CRC screening test.
- ColoFuture reported sensitivity for CRC of 94% with specificity of 97% and advanced adenoma (AA) sensitivity of 80%.
- eAArly DETECT reported sensitivity for colorectal cancer of 97% with a specificity of 97% and a sensitivity for advanced adenoma of 82%.
- Final preparations for Pivotal FDA PMA clinical trial (ReconAAsense) evaluating gold standard self-administered CRC test - on track to commence patient enrollment in 2024.
- Established partnership with Trusted Health Advisors, a market leader in supporting the U.S. launches and management of commercial programs for diagnostic products – collaboration led by Jay Wohlgemuth, former Chief Medical & Scientific Officer of Quest Diagnostics.
- Expanded international commercialization of ColoAlert®, a highly efficacious and easy-to-use DNA-based detection test for CRC being sold via Company’s unique business model of marketing products via partnerships with third-party laboratories versus the traditional methodology of operating a single facility.
- Established commercial operations in major markets including Spain, Poland, Romania, Portugal, Israel, and the UK.
The company opened its own physician-led laboratory, ‘European Oncology Lab’ (EOL), thereby offering ColoAlert® as a laboratory medical service directly to physicians and patients, granting potential for further expansion into Germany's private health insurance segment where the DNA-based test already receives reimbursement.
Condensed Consolidated Financial Statements (unaudited):
| Mainz Biomed N.V. | ||||||||
| Condensed Consolidated Statements of Profit or Loss and Comprehensive Loss (unaudited) | ||||||||
| (in U.S. Dollars) | ||||||||
| Years ended | ||||||||
| December 31, | ||||||||
| 2023 | 2022 | |||||||
| Revenue | $ | 895,479 | $ | 529,877 | ||||
| Cost of revenue | 385,820 | 347,726 | ||||||
| Gross profit | 509,659 | 182,151 | ||||||
| Gross margin | 57% | 34% | ||||||
| Operating expenses: | ||||||||
| Sales and marketing | 6,158,477 | 6,396,906 | ||||||
| Research and development | 9,590,393 | 5,019,366 | ||||||
| General and administrative | 11,405,471 | 15,209,919 | ||||||
| Total operating expenses | 27,154,341 | 26,626,191 | ||||||
| Loss from operations | (26,644,682) | (26,444,040) | ||||||
| Other Expenses, net | 348,955 | 56,704 | ||||||
| Income (loss) before income tax | (26,295,727) | (26,387,336) | ||||||
| Income taxes provision | - | - | ||||||
| Net loss | $ | (26,295,727) | $ | (26,387,336) | ||||
| Foreign currency translation gain (loss) | (504,494) | 49,703 | ||||||
| Comprehensive loss | $ | (26,800,221) | $ | (26,337,633) | ||||
| Basic and diluted loss per ordinary share | $ | (1.62) | $ | (1.86) | ||||
| Weighted average number of ordinary shares outstanding | 16,242,334 | 14,157,492 | ||||||
| Mainz Biomed N.V. | |||||||||
| Condensed Consolidated Statements of Financial Position (unaudited) | |||||||||
| (in U.S. Dollars) | |||||||||
| December 31, | December 31, | ||||||||
| 2023 | 2022 | ||||||||
| ASSETS | |||||||||
| Current Assets | |||||||||
| Cash | $ | 7,070,925 | $ | 17,141,775 | |||||
| Trade and other receivables, net | 93,555 | 66,984 | |||||||
| Inventories | 613,638 | 175,469 | |||||||
| Prepaid expenses and other current assets | 1,201,670 | 994,113 | |||||||
| Total Current Assets | 8,979,788 | 18,378,341 | |||||||
| Property and equipment, net | 1,702,317 | 661,692 | |||||||
| Intangible assets | 3,394,645 | - | |||||||
| Right-of-use assets | 1,332,170 | 1,177,695 | |||||||
| Other assets | 108 | 23,275 | |||||||
| Total assets | $ | 15,409,028 | $ | 20,241,003 | |||||
| LIABILITIES AND SHAREHOLDERS' EQUITY | |||||||||
| Current Liabilities | |||||||||
| Accounts payable and accrued liabilities | $ | 3,484,317 | $ | 2,916,679 | |||||
| Deferred Revenue | 138,889 | - | |||||||
| Current maturities of long-term debt | 4,936,428 | 1,040,573 | |||||||
| Intellectual property acquisition liability - related party | 388,839 | - | |||||||
| Lease liabilities | 288,463 | 285,354 | |||||||
| Total current liabilities | 9,236,936 | 4,242,606 | |||||||
| Long term debt | 1,030,166 | 943,214 | |||||||
| Lease liabilities | 1,165,723 | 959,116 | |||||||
| Intellectual property acquisition liability - related party | 726,977 | - | |||||||
| Total Liabilities | 12,159,802 | 6,144,936 | |||||||
| Shareholders' equity | |||||||||
| Share capital | 235,818 | 164,896 | |||||||
| Share premium | 51,507,526 | 38,831,542 | |||||||
| Reserve | 21,286,215 | 18,079,741 | |||||||
| Accumulated deficit | (69,328,021) | (43,032,294) | |||||||
| Accumulated other comprehensive income | (452,312) | 52,182 | |||||||
| Total shareholders' equity | 3,249,226 | 14,096,067 | |||||||
| Total liabilities and shareholders' equity | $ | 15,409,028 | $ | 20,241,003 | |||||
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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 (Dollinger et al., 2018, Franck et al. 2024). The product is commercially available in select EU countries through a network of leading independent laboratories, corporate health programs and via direct sales. To receive marketing approval in the US, ColoAlert® will be evaluated in the FDA-registration trial ‘ReconAAsense.’ Once approved in the US, 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.
About Colorectal Cancer
Colorectal cancer (CRC) is the third most common cancer globally, with more than 1.9 million new cases reported in 2020, according to World Cancer Research Fund International. The US Preventive Services Task Force recommends that screening with stool DNA tests such as ColoAlert® should be conducted once every three years starting at age 45. Each year in the US, 16.6 million colonoscopies are performed. However, roughly one-third of US residents aged 50-75 have never been screened for colon cancer. This gap in screening represents a $4.0B+ total market opportunity in the US.
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 based on real-time Polymerase Chain Reaction-based (PCR) multiplex detection of molecular-genetic biomarkers in stool samples. ColoAlert® is currently marketed across Europe. The Company is planning to run a pivotal FDA clinical study for US regulatory approval. Mainz Biomed’s product candidate portfolio also includes PancAlert, an early-stage pancreatic cancer screening test. To learn more, visit mainzbiomed.com.
For media inquiries
In Europe:
MC Services AG
Anne Hennecke/Caroline Bergmann
+49 211 529252 20
mainzbiomed@mc-services.eu
In the U.S.:
Blueprint Life Science Group
Hershel Berry
+1 415 505 3749
hberry@bplifescience.com
For investor inquiries, please contact info@mainzbiomed.com
Forward-Looking Statements
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 annual report on Form 20-F filed on April 8, 2024. 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.
