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 ItalyAcquired 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 sharesInitiated 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 2023Initiated ReconAAsense, U.S. Pivotal Clinical Study with Company’s CRC screening test; anticipate commencing patient enrollment in the second half of 2023Enhanced 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 developmentAchieved 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 (Gies et al., 2018). 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 NV
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 running 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 or follow us on LinkedIn, Twitter and Facebook.
For media inquiries, please contact press@mainzbiomed.com
In Europe:
MC Services AG
Anne Hennecke/Caroline Bergmann
+49 211 529252 20
mainzbiomed@mc-services.eu
In the US:
Spectrum Science
Melissa Laverty/Valerie Enes
+1 540 272 6465
mainz@spectrumscience.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 May 5, 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.
