MYNZ Mainz BioMed NV

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 6-K

 

REPORT OF FOREIGN PRIVATE ISSUER

PURSUANT TO RULE 13a-16 OR 15d-16

UNDER THE SECURITIES EXCHANGE ACT OF 1934

 

For the month of October 2024

 

Commission File No. 001-41010

 

MAINZ BIOMED N.V.

(Translation of registrant’s name into English)

 

Robert Koch Strasse 50
55129 Mainz
Germany

(Address of principal executive office)

 

Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F

 

Form 20-F ☒     Form 40-F ☐

 

 

 

Other Events

 

As previously disclosed by Mainz Biomed N.V. (the “Company”) in a Current Report on Form 6-K on October 18, 2024, the Company N.V. made available its Management’s Discussion and Analysis of Financial Condition and Results of Operations, and unaudited Financial Statements each for the six months ended June 30, 2024.

 

Furnished as Exhibit 99.1 to this Report on Form 6-K is a press release of dated October 21, 2024, announcing the Company’s results for the six months ended June 30, 2024.

 

Exhibit No.		Exhibit
99.1		Press Release dated October 21, 2024

 

 

SIGNATURE

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

Date: October 21, 2024	By:	/s/ William J. Caragol
	Name:	William J. Caragol
	Title	Chief Financial Officer

 

 

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Exhibit 99.1

 

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

 

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, US – MAINZ, Germany – October 21, 2024 — 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:

 

o

The continued growth of its ColoAlert® business in Europe;

 

o

Development of its next generation colorectal cancer screening product; and

 

o

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.

 

 

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