MYNZ Mainz BioMed NV

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

Please visit Mainz Biomed’s official website for investors at mainzbiomed.com/investors/ for more information.

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

Please visit Mainz Biomed’s official website for investors at mainzbiomed.com/investors/ for more information.

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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 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 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 AGAnne Hennecke/Caroline Bergmann+49 211 529252 20mainzbiomed@mc-services.eu

In the U.S.:Blueprint Life Science GroupHershel Berry+1 415 505 3749hberry@bplifescience.com

For investor inquiries, please contact info@mainzbiomed.com

Forward-Looking StatementsCertain 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.