Mainz Biomed Reports Mid-Year 2024 Financial Results and Provides Corporate Update

Rhea-AI Summary

Mainz Biomed N.V. (NASDAQ:MYNZ) reported mid-year 2024 financial results and provided a corporate update. Key highlights include:

- Revenue increased 4% year-over-year
- Loss from operations decreased by 32%
- Presented groundbreaking results at DDW 2024 and ASCO 2024, showing high sensitivity for colorectal cancer (CRC) and advanced adenomas
- Improved ColoAlert® product with new DNA stabilizing buffer
- Expanded collaboration with Liquid Biosciences for pancreatic cancer detection
- Received FDA feedback on breakthrough device designation
- Announced strategic focus on three key initiatives for 2024-2025

The company aims to grow its ColoAlert® business in Europe, develop its next-generation CRC screening product, and conduct a 2,000-patient study (eAArly DETECT 2) in the U.S. Mainz Biomed also implemented cost reductions to streamline operations.

Positive

• Revenue increased by 4% year-over-year
• Loss from operations decreased by 32%
• Net loss decreased by 26%
• Presented promising study results with 92% sensitivity for CRC and 82% for advanced adenomas
• Improved ColoAlert® product efficiency with new DNA stabilizing buffer
• Expanded collaboration for pancreatic cancer detection test development

Negative

• Net loss of $11,023,762 for the first half of 2024
• Cash position decreased from $7,070,925 to $977,764
• Total shareholders' equity turned negative, from $3,249,226 to -$4,138,700

Insights

Financial Analyst

Mainz Biomed's mid-year 2024 results show mixed signals. Revenue increased by 4% year-over-year, reaching $520,773, which is positive but modest growth. More significantly, the company reduced its loss from operations by 32% to $9,807,328, demonstrating improved cost management.

However, the company's financial position remains precarious. Cash reserves dropped from $7,070,925 at the end of 2023 to just $977,764 by June 2024, a 86% decrease. This burn rate is concerning and suggests the need for additional financing soon.

The company's strategic shift to focus on three key initiatives is prudent given its financial constraints. The emphasis on growing ColoAlert® sales in Europe could help improve near-term revenues, while the development of next-generation products and the eAArly DETECT 2 study aim to build long-term value. However, investors should closely monitor cash burn and potential dilution from future capital raises.

Medical Research Analyst

Mainz Biomed's clinical results for their colorectal cancer (CRC) screening tests are impressive. The eAArly DETECT study showed 97% sensitivity for CRC and 82% for advanced precancerous lesions, with 100% detection of high-grade dysplasia. The pooled results from ColoFuture and eAArly DETECT studies confirmed strong performance with 92% sensitivity for CRC and 82% for advanced adenomas.

These results are significantly better than current standard screening methods, potentially positioning Mainz Biomed's products as game-changers in CRC detection. The high sensitivity for precancerous lesions is particularly noteworthy, as it could lead to earlier interventions and better patient outcomes.

The company's decision to conduct the 2,000-patient eAArly DETECT 2 study with average-risk patients is a smart move to address FDA feedback and strengthen their case for breakthrough device designation. This study, set to read out in H2 2025, could be a significant catalyst if it confirms the earlier impressive results in a larger, more representative population.

Revenue increases 4% year over year while loss from operations decreases by 32%

Pooled Results of ColoFuture and eAArly DETECT studies published at ASCO showing groundbreaking performance with sensitivity for CRC of 92% and 82% for advanced adenomas, including 95.8% detection of high-grade dysplasia

Company highlights its path to success for 2025

BERKELEY, Calif. and MAINZ, Germany, Oct. 21, 2024 (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 first half of 2024, an update on 2024 accomplishments, and its outlook for the end of the year and strategic direction for 2025.

Key 2024 Accomplishments

• During the first six months of 2024, the Company’s revenue increased by 4% year over year while the loss from operations and net loss decreased by 32% and 26%, respectively. These decreases are the result of the Company’s efforts to reduce costs during the first half of the year.
• 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 (CRC) 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, demonstrating the significance of its innovative screening approach. 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.
• The Company announced significant improvements to its ColoAlert^® product, currently being commercialized across Europe and in select international markets. These updates aim to enhance customer satisfaction and streamline lab operations. To increase screening/lab efficiency, Mainz Biomed introduced a novel DNA stabilizing buffer capable of accommodating varying sample volumes, addressing a common issue in the industry where samples are often either underfilled or overfilled, rendering them unsuitable for laboratory analysis. The new proprietary buffer used in ColoAlert^® significantly reduces the necessity for additional sample submissions, thereby decreasing the time for the patients to obtain their results. This enhancement has enabled ColoAlert^® to achieve the industry’s lowest retesting rates, ensuring that screening outcomes are delivered within just 2 – 3 days upon arrival at the laboratory.  
• The Company expanded its collaboration with Liquid Biosciences to Mainz Biomed’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. The first phase of the collaboration included the evaluation of biomarkers from the Company’s research program co-funded by the German Federal Ministry for Education and Research, and applied a single algorithm developed by Liquid Biosciences using its EMERGE platform. The results of this feasibility analysis were promising, leading the Company and Liquid Biosciences to believe that a PancAlert diagnostic test could, in the future, be combined with Mainz Biomed’s colorectal cancer screening product.
  

Post-period Update

• In September 2024, Mainz Biomed announced encouraging feedback received from the FDA for the breakthrough device designation with the request to expand the current clinical data set with additional average risk population.
• In October 2024, the Company made the 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;
  • 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 in the second half of 2025 (eAArly DETECT 2). With eAArly DETECT 2, the Company addresses the recent FDA feedback and prepares for a new submission for breakthrough device designation with an expanded data set, including a larger average-risk patient population.
    

In line with these strategic initiatives, the Company restructured its operations and implemented cost reductions which included decreasing its operating costs, primarily driven by the reduction of personnel and external consulting costs.

“2024 has been a transitional year for Mainz Biomed. While navigating through a period of difficult markets, especially for small cap technology stocks, we are proud to have achieved many significant accomplishments to date,” commented Guido Baechler, Chief Executive Officer of Mainz Biomed. “As the Board and management team evaluated our path forward, we believe that a narrower focus on key strategic initiatives gives us the best opportunity to unlock shareholder value in the remainder of 2024 and 2025.”

Condensed Consolidated Financial Statements (unaudited):

Mainz Biomed N.V.
Condensed Consolidated Statements of Profit or Loss and Comprehensive Loss (unaudited)
(in U.S. Dollars)
		Six months ended
		June 30,
		2024			2023
	Revenue	$	520,773		$	499,049
	Cost of sales		201,735			211,310
	Product margin		319,038			287,739
			61%			58%
	Operating expenses:
	Sales and marketing		2,361,105			3,992,975
	Research and development		3,242,622			5,481,229
	General and administrative		4,522,639			5,227,181
	Total operating expenses		10,126,366			14,701,385
	Loss from operations		(9,807,328)			(14,413,646)
	Other income (expense)
	Other income		105,851			125,968
	Change in fair value of convertible debt		(528,210)			45,000
	Finance expense		-			(250,000)
	Accretion and interest expense		(659,473)			(88,759)
	Other expense		(134,602)			(231,206)
	Total other income (expense)		(1,216,434)			(398,997)
	Income (loss) before income tax		(11,023,762)			(14,812,643)
	Income taxes provision		-			-
	Net loss	$	(11,023,762)		$	(14,812,643)
	Foreign currency translation gain (loss)		(62,366)			(150,596)
	Comprehensive loss	$	(11,086,128)		$	(14,963,239)
	Basic and diluted loss per ordinary share	$	(0.49)		$	(1.00)
	Weighted average number of ordinary shares outstanding		22,350,033			14,803,243

Condensed Consolidated Financial Statements (unaudited):

Mainz Biomed N.V.
Condensed Consolidated Statements of Financial Position (unaudited)
(in U.S. Dollars)
			June 30,			December 31,
			2024			2023
ASSETS
Current Assets
	Cash		$	977,764		$	7,070,925
	Trade and other receivables, net			139,414			93,555
	Inventories			520,531			613,638
	Prepaid expenses and other current assets			751,994			1,201,778
Total Current Assets				2,389,703			8,979,896
	Property and equipment, net			1,625,373			1,702,317
	Intangible assets			3,206,054			3,394,645
	Right-of-use assets			1,232,900			1,332,170
	Other assets			-
	Total assets		$	8,454,030		$	15,409,028
LIABILITIES AND SHAREHOLDERS' EQUITY
Current Liabilities
	Accounts payable and accrued liabilities		$	2,903,873		$	3,184,381
	Accounts payable and accrued expense - related party			426,637			299,936
	Deferred revenue			116,679			138,889
	Convertible debt			5,842,003			4,903,310
	Convertible debt - related party			32,140			33,118
	Silent partnership			49,036			-
	Intellectual property acquisition liability - related party			324,003			388,839
	Lease liabilities			319,573			288,463
Total current liabilities				10,013,944			9,236,936
	Silent partnerships			713,856			758,812
	Silent partnerships - related party			267,206			271,354
	Lease liabilities			1,046,163			1,165,723
	Intellectual property acquisition liability - related party			551,561			726,977
	Total Liabilities			12,592,730			12,159,802
Shareholders' equity
Share capital				276,378			235,818
Share premium				54,136,785			51,507,526
Reserve				22,314,598			21,286,215
Accumulated deficit				(80,351,783)			(69,328,021)
Accumulated other comprehensive income (loss)				(514,678)			(452,312)
Total shareholders' equity				(4,138,700)			3,249,226
Total liabilities and shareholders' equity			$	8,454,030		$	15,409,028

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

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About Mainz Biomed NV
Mainz Biomed develops market-ready molecular genetic diagnostic solutions for life-threatening conditions. The Company’s flagship product is ColoAlert^®, a non-invasive and easy-to-use, early-detection diagnostic test for colorectal cancer with high sensitivity and specificity. ColoAlert^® is marketed in Europe and the United Arab Emirates. The Company is currently preparing 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 based on real-time Polymerase Chain Reaction-based (PCR) multiplex detection of molecular-genetic biomarkers in stool samples. To learn more, visit mainzbiomed.com or follow us on LinkedIn, Twitter and Facebook.

For media inquiries
MC Services AG
Anne Hennecke/Caroline Bergmann
+49 211 529252 20
mainzbiomed@mc-services.eu

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 April 9, 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.

FAQ

What were Mainz Biomed's (MYNZ) key financial results for mid-year 2024?

Mainz Biomed reported a 4% increase in revenue year-over-year, a 32% decrease in loss from operations, and a 26% decrease in net loss for the first half of 2024.

What were the sensitivity rates for CRC detection in Mainz Biomed's (MYNZ) studies?

Mainz Biomed's combined ColoFuture and eAArly DETECT studies showed 92% sensitivity for colorectal cancer (CRC) and 82% for advanced adenomas, including 95.8% detection of high-grade dysplasia.

What are Mainz Biomed's (MYNZ) strategic initiatives for 2024-2025?

Mainz Biomed is focusing on three key initiatives: growing ColoAlert® business in Europe, developing a next-generation colorectal cancer screening product, and conducting a 2,000-patient study (eAArly DETECT 2) in the U.S.

How did Mainz Biomed (MYNZ) improve its ColoAlert® product in 2024?

Mainz Biomed introduced a novel DNA stabilizing buffer for ColoAlert®, reducing the need for additional sample submissions and achieving the industry's lowest retesting rates, with results delivered within 2-3 days upon lab arrival.