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.