Mainz Biomed Reports 2024 Financial Results and Provides Corporate Update

Rhea-AI Summary

Mainz Biomed (NASDAQ:MYNZ) reported its 2024 financial results, highlighting a 33% year-over-year increase in lab network revenue for ColoAlert® in Europe. The company achieved significant cost reductions, resulting in a 30% decrease in operating loss and an 18% reduction in net loss.

Key developments include strategic partnerships with Thermo Fisher Scientific for next-generation colorectal cancer screening product development and Quest Diagnostics for clinical trial services. The company completed an $8.0 Million follow-on offering and focused on three core initiatives: European ColoAlert® business growth, next-generation product development, and the 2,000-patient eAArly DETECT 2 study.

Financial highlights for 2024 include:

• Revenue: $893,991
• Gross profit: $574,883 (64% margin)
• Net loss: $21.65 million
• Cash position: $6.24 million as of December 31, 2024

Positive

• 33% year-over-year increase in lab network revenue
• 30% reduction in operating loss and 18% decrease in net loss
• Strategic partnership with Thermo Fisher Scientific for product development
• Regained full compliance with Nasdaq listing requirements
• Strong clinical results with 97% sensitivity for colorectal cancer detection

Negative

• Net loss of $21.65 million in 2024
• Decrease in direct-to-consumer sales due to unprofitable channel
• Cash position decreased to $6.24M from $7.07M year-over-year
• Share dilution from $8.0M follow-on offering

Insights

Financial Analyst

Mainz Biomed's 2024 financial results reflect meaningful operational improvements amid continued challenges. The 33% year-over-year growth in lab network revenue demonstrates strong market adoption for ColoAlert® in Europe, though total revenue remained essentially flat at $893,991 as the company discontinued its unprofitable direct-to-consumer channel. This strategic pivot appears effective, as evidenced by the 30% reduction in operating loss and 18% decrease in net loss.

The improved gross margin of 64% (up from 57%) indicates better operational efficiency, creating potential for future profitability if revenue scale continues. However, the $21.65 million annual net loss against a cash position of $6.24 million suggests continued financing needs without significant revenue acceleration. The $8 million follow-on offering provides some runway extension but with shareholder dilution.

Strategic partnerships with Thermo Fisher Scientific and Quest Diagnostics represent significant validations of Mainz's technology and open commercial pathways that could accelerate market adoption. The focus on three key initiatives demonstrates disciplined management and strategic clarity.

The resolution of Nasdaq compliance issues removes a significant regulatory risk. The balance sheet shows reduced total liabilities ($7.19 million vs. $12.16 million year-over-year), indicating improved financial health, though long-term sustainability remains dependent on successful commercialization of the company's diagnostics pipeline.

Medical Diagnostics Expert

Mainz Biomed's clinical data presents compelling evidence for their colorectal cancer screening technology. The eAArly DETECT study results showing 97% sensitivity for colorectal cancer and 82% for advanced precancerous lesions place their test among the top performers in the field. Particularly notable is the 100% detection rate for high-grade dysplasia patients, addressing a critical clinical need for early intervention.

The strategic collaboration with Thermo Fisher Scientific provides Mainz access to sophisticated instrumentation and information translation systems that should enhance their mRNA-based testing capabilities. This partnership model leverages complementary strengths - Mainz's proprietary biomarkers with Thermo Fisher's established technological infrastructure.

The Quest Diagnostics agreement for the ReconAAsense study represents a significant operational advantage for their FDA pathway. With approximately 15,000 subjects across 150 U.S. sites, this study design should provide robust validation data. The follow-on eAArly DETECT 2 study addressing FDA feedback shows appropriate regulatory strategy adaptation.

The expansion into pancreatic cancer detection through the Liquid Biosciences collaboration indicates promising diversification. The preliminary results showing 95% sensitivity and 98% specificity for pancreatic cancer detection are remarkable for this notoriously difficult-to-diagnose condition, though validation in larger clinical cohorts will be essential to confirm these findings.

Overall, Mainz is effectively transitioning from technology development to clinical validation with a clear focus on regulatory approval pathways, while strengthening their scientific credibility through peer recognition at major conferences like DDW and ASCO.

Lab network revenue increased by 33% year over year, reflecting strong demand for ColoAlert^® in Europe

Operating loss decreased by 30% and net loss by 18%, driven by targeted cost reductions and a sharper strategic focus

Strategic partnerships with industry leaders mark key progress

Company highlights its early accomplishments for 2025

BERKELEY, Calif. and MAINZ, Germany, April 01, 2025 (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 year ended December 31, 2024, a summary on 2024 accomplishments, and an update on corporate developments for early 2025.

Key 2024 Accomplishments

• Mainz Biomed and Thermo Fisher Scientific signed a collaboration agreement for the development of the Company’s next generation colorectal cancer (CRC) screening product for global markets. The agreement will enable Mainz Biomed and Thermo Fisher to jointly develop and potentially commercialize Mainz Biomed’s next generation colorectal cancer screening product. The collaboration will harness Thermo Fisher’s powerful technologies, instrumentation and information translation systems to allow Mainz Biomed to develop the proprietary assays for its mRNA-based next-generation CRC screening tests which are redefining standards in early cancer detection.
• Mainz Biomed entered into an agreement with Quest Diagnostics to provide clinical trial laboratory services for Mainz Biomeds’s ReconAAsense study, a prospective clinical study that will include approximately 15,000 subjects from 150 sites across the United States to develop data supporting FDA validation of the next generation test. In addition, Mainz Biomed will provide Quest with the option to exercise semi-exclusive rights to provide testing services based on the test kit for an eighteen-month period, assuming its approval by the FDA.
• Mainz Biomed executed an $8.0 Million follow-on offering for 1,367,521 units sold at an offering price of $5.85 per unit, priced at-the-market under Nasdaq rules. Each unit included an ordinary share, a Series A warrant and a Series B warrant. Each Series A warrant is immediately exercisable at an exercise price of $5.85 per share and will expire five years from the date of issuance. Each Series B warrant is immediately exercisable at an exercise price of $5.85 per share and will expire on the earlier of 30 days following receipt of results from the Company’s eAArly Detect 2 study and one year from the date of issuance.
• In October 2024, the Company made a strategic decision to focus its efforts on three key initiatives for the remainder of 2024 and into 2025 in order to maximize shareholder value. Those initiatives are:
  • The continued growth of its ColoAlert^® business in Europe through its distribution/lab partner network;
  • Development of its next generation colorectal cancer screening product; and
  • Running a 2,000 patient study, with average risk patients in the U.S., to read out by the end of 2025 (eAArly DETECT 2). With eAArly DETECT 2, the Company addresses FDA feedback and prepares for a new submission for breakthrough device designation with an expanded data set, including a larger average-risk patient population.
• During 2024, Mainz Biomed’s revenue from sales through its lab partner network increased by 33% year over year; this increase was tempered by a decrease in direct-to-consumer sales as the Company ceased its efforts in that unprofitable channel.
• In 2024, Mainz Biomed’s loss from operations and net loss decreased by 30% and 18%, respectively. These decreases are the result of the Company’s efforts to reduce costs and focus on its three key initiatives for 2025.
• Mainz Biomed published key findings from its groundbreaking eAArly DETECT study during a poster presentation at the renowned Digestive Disease Week (DDW) 2024 in Washington D.C. The Company was awarded as a Poster of Distinction by the Digestive Disease Week judges for the presentation of industry leading results: 97% sensitivity for colorectal cancer and 82% for advanced precancerous lesions. The eAArly DETECT results demonstrated that within the advanced precancerous lesion patients, 100% of those patients with high grade dysplasia were detected.
• The Company presented pivotal data from its largest cohort to date during a poster presentation at the American Society of Clinical Oncology (ASCO) 2024 Annual Meeting in Chicago, Illinois. This data combined results from the ColoFuture and eAArly DETECT studies including additional patient samples collected since the first reported study results. The new study data confirmed previous ColoFuture and eAArly DETECT study performance with sensitivity for CRC of 92% and 82% for advanced adenomas, including 96% detection of high-grade dysplasia.
• Mainz Biomed expanded its collaboration with Liquid Biosciences to the Company’s next-generation detection test for pancreatic cancer. The companies are leveraging Liquid Biosciences proprietary AI analysis technology platform (EMERGE) to extend and optimize the selection of novel biomarkers for PancAlert.

Early 2025 Updates

• On January 23, 2025, the Company received formal notice from Nasdaq confirming that it had regained compliance with the minimum stockholders’ equity requirement for continued listing on the Nasdaq Capital Market set forth in Listing Rule 5550(b)(1). Mainz Biomed had previously received confirmation that it had regained compliance with the minimum bid price requirement set forth in Nasdaq Listing Rule 5550(a)(2). Mainz Biomed is now in full compliance with all Nasdaq continued listing requirements.
• The Company reported the first patient has been enrolled in eAArly DETECT 2, a feasibility study to evaluate the Company’s next-generation colorectal cancer (CRC) test. The test integrates its proprietary mRNA biomarkers, an AI-developed algorithm, and a FIT test over a population of approximately 2,000 average-risk patients to validate the industry-leading results of previous feasibility studies and support the transition of CRC screening to CRC prevention. This keeps the Company on schedule to report top-line results by the end of 2025.
• Signed a license and option agreement with Liquid Biosciences to access novel mRNA biomarkers for early detection of pancreatic cancer via blood test. Independent validation of the algorithm-biomarker combination showed 95% sensitivity and 98% specificity.
  

“We are proud of the accomplishments our team achieved in 2024, which was a transitional year for Mainz Biomed,” commented Guido Baechler, Chief Executive Officer of Mainz Biomed. “While navigating through a period of difficult market conditions, especially for small cap healthcare and technology stocks, we reached many significant milestones. As we look at our early results for 2025, we are encouraged by the progress of our eAArly DETECT 2 study and by our recently announced discovery and license of a suite of mRNA biomarkers, showing outstanding preliminary results for a blood-based pancreatic cancer detection test.”

Condensed Consolidated Financial Statements (unaudited):

	Mainz Biomed N.V.
	Condensed Consolidated Statements of Financial Position (unaudited)
	(in U.S. Dollars)
			December 31,			December 31,
			2024			2023
ASSETS
Current Assets
	Cash		$	6,235,670		$	7,070,925
	Trade and other receivables, net			50,815			93,555
	Inventories			372,870			613,638
	Prepaid expenses and other current assets			1,184,675			1,201,778
Total Current Assets				7,844,030			8,979,896
	Property and equipment, net			1,365,144			1,702,317
	Intangible assets			3,017,462			3,394,645
	Right-of-use assets			1,011,531			1,332,170
	Total assets		$	13,238,167		$	15,409,028
LIABILITIES AND SHAREHOLDERS' EQUITY
Current Liabilities
	Accounts payable and accrued liabilities		$	2,853,572		$	3,484,317
	Deferred Revenue			-			138,889
	Current maturities of long-term debt			2,125,254			4,936,428
	Intellectual property acquisition liability - related party			690,575			388,839
	Lease liabilities			280,145			288,463
Total current liabilities				5,949,546			9,236,936
	Long term debt			-			1,030,166
	Lease liabilities			865,982			1,165,723
	Intellectual property acquisition liability - related party			376,096			726,977
	Total Liabilities			7,191,624			12,159,802
Shareholders' equity
Share capital				922,125			235,818
Share premium				69,065,027			51,507,526
Reserve				27,594,947			21,286,215
Accumulated deficit				(90,978,684)			(69,328,021)
Accumulated other comprehensive income				(556,872)			(452,312)
Total shareholders' equity				6,046,543			3,249,226
Total liabilities and shareholders' equity			$	13,238,167		$	15,409,028

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,
			2024			2023
	Revenue		$	893,991		$	895,479
	Cost of revenue			319,108			385,820
	Gross profit			574,883			509,659
	Gross margin			64%			57%
	Operating expenses:
	Sales and marketing			6,581,333			6,158,477
	Research and development			5,839,033			9,590,393
	General and administrative			6,572,765			11,405,471
	Restructuring expense			277,160			-
	Total operating expenses			19,270,291			27,154,341
	Loss from operations			(18,695,408)			(26,644,682)
	Other income (expense), net			(2,955,255)			348,955
	Income (loss) before income tax			(21,650,663)			(26,295,727)
	Income taxes provision			-			-
	Net loss		$	(21,650,663)		$	(26,295,727)
	Foreign currency translation gain (loss)			(104,560)			(504,494)
	Comprehensive loss		$	(21,755,223)		$	(26,800,221)
	Basic and dilutive loss per ordinary share		$	(22.36)		$	(64.76)
	Weighted average number of ordinary shares outstanding			968,234			406,058

Please visit Mainz Biomed’s official website for investors at mainzbiomed.com/investors/ for more information
Please follow us to stay up to date:
LinkedIn
X (Previously Twitter)
Facebook
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. ColoAlert^® is marketed across Europe. The Company is currently running a development study to finalize with the next gen CRC screening test as preparation for the pivotal FDA clinical study for US regulatory approval. Mainz Biomed’s product candidate portfolio also includes PancAlert, an early-stage pancreatic cancer screening test based on real-time Polymerase Chain Reaction-based (PCR) multiplex detection of molecular-genetic biomarkers. To learn more, visit mainzbiomed.com or follow us on LinkedIn, Twitter and Facebook.

For media inquiries
MC Services AG
Anne Hennecke / Maximilian Schur
+49 211 529252 17
mainzbiomed@mc-services.eu
For investor inquiries, please contact ir@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; and (iii) 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 March 31, 2025. 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.

FAQ

What was MYNZ's revenue growth in lab network sales for 2024?

Mainz Biomed reported a 33% year-over-year increase in lab network revenue for ColoAlert® in Europe during 2024.

How much did MYNZ reduce its operating loss in 2024?

MYNZ decreased its operating loss by 30% in 2024 through targeted cost reductions and strategic focus.

What are the key terms of MYNZ's $8.0 Million follow-on offering in 2024?

The offering included 1,367,521 units at $5.85 per unit, with each unit containing one ordinary share, a Series A warrant, and a Series B warrant.

What were the clinical results of MYNZ's eAArly DETECT study presented at DDW 2024?

The study showed 97% sensitivity for colorectal cancer and 82% for advanced precancerous lesions, with 100% detection of high-grade dysplasia cases.

What is the timeline for MYNZ's eAArly DETECT 2 study results?

The company expects to report top-line results from the 2,000-patient eAArly DETECT 2 study by the end of 2025.