MYNZ Mainz BioMed NV

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 EndedDecember 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 ColoAlertColoAlert®, 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 CancerColorectal 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 NVMainz 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 AGAnne Hennecke/Caroline Bergmann+49 211 529252 20mainzbiomed@mc-services.eu

In the US:

Spectrum ScienceMelissa Laverty/Valerie Enes+1 540 272 6465mainz@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.