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Organization and Description of Business

12 Months Ended

Dec. 31, 2025

Organization and Description of Business [Abstract]

ORGANIZATION AND DESCRIPTION OF BUSINESS

NOTE 1 – ORGANIZATION AND DESCRIPTION OF BUSINESS

Organization and Operations

Mainz Biomed N.V. (the “Company”) is domiciled in the Netherlands. The Company’s registered office is at Robert-Koch Strasse 50, 55129 Mainz, Germany with substantially all of its operations in Germany. The Company was formed in 2021 to acquire the business of Mainz Biomed Germany GmbH.

The Company has been engaged in developing and selling in-vitro diagnostic (“IVD”) tests for the early detection of cancer. The Company’s ColoAlert product is being marketed and sold in European markets. During 2025, the Company was developing its next-generation colorectal cancer screening and pancreatic cancer screening products and intend to launch them in the United States and Europe in the future. The Company operated a clinical diagnostic laboratory, however, it primarily distributed the Company’s IVD kits to third-party laboratories in Europe.

Restructuring

During July 2024 and October 2024, the Company restructured its operations to focus on its ColoAlert business in Europe, the development of its next-generation product, and planning for the Early Detect 2 clinical study in the U.S. in 2025. In line with that focus, the Company implemented cost-reduction efforts, including reducing its operating costs, reducing personnel by 65%, reducing external consulting costs, and selling its European Oncology Lab (“EOL”) business in St. Ingbert, Germany. The sale of the EOL business included a payment to the Company of €31,511 ($32,785). Additionally, the Company amended the employment contracts of its CEO and CFO, reducing their salaries to 60% and 50% of their then-current salaries, respectively, effective November 1, 2024. For the year ended December 31, 2024, the Company recorded severance expenses and impairment loss from this transaction of $277,160 as restructuring expense and gain on sale of EOL of $28,328.

Reverse stock split

On December 3, 2024, the Company implemented a 1-for-40 reverse stock split of its issued and outstanding shares. The reverse stock split was authorized by the Board of Directors of the Company, pursuant to shareholder approval granted at its Extraordinary Shareholders Meeting on November 20, 2024. The Company amended the par value of share capital from €0.40 to €0.01 per share in November 2025.

All share and per share information in these financial statements retroactively reflects this reverse stock split.

Reclassification

Certain amounts in the prior year’s Consolidated Financial Statements and Notes have been recast to conform to the 2025 presentation, most notably, previously prepaid expense was offset by a short term financing loan. Refer to Note 10.

		Originally reported				Recast				Currently reported
Prepaid expense		$	1,184,675			$	176,814			$	1,361,489
Loan payable		$	-			$	176,814			$	176,814

Going concern

The Company’s consolidated financial statements have been prepared on the assumption that the Company will continue as a going concern, which contemplates the realization of assets and the liquidation of liabilities in the normal course of business.

As of December 31, 2025, the Company had an accumulated deficit of approximately $104.9 million, a net working capital deficit of approximately $1.9 million, and a cash balance of $889,091. During the year ended December 31, 2025, the Company incurred a net loss of approximately $16.2 million.

The Company has suffered recurring losses from operations, negative working capital and does not have an established source of revenues sufficient to cover its operating costs. These conditions raise substantial doubt about the Company’s ability to continue as a going concern. The consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty. Management evaluated conditions and events that raise substantial doubt and the Company’s plans to mitigate those conditions over the one-year look-forward period from the date these consolidated financial statements are issued.

The Company’s ability to continue as a going concern depends on its ability to successfully execute its business plan and eventually achieve profitable operations.

During the next year, the Company’s foreseeable cash requirements will relate to continual development of the operations of its business and maintaining its good standing in the industry. The Company may experience a cash shortfall and be required to raise additional capital.

Historically, the Company has relied upon funds from its stockholders and loans from third parties. Management may raise additional capital through future public or private offerings of the Company’s stock or through loans from private investors, although there can be no assurance that it will be able to obtain such financing. The Company’s failure to do so could have a material and adverse effect upon its operations and its stockholders.

Management’s plans also include reducing or deferring certain discretionary expenditures and pursuing strategic partnerships and/or revenue-generating contracts, however, there can be no assurance these plans will be effectively implemented or be successful.

The Company believes that its currently available cash on hand, together with additional financing described above, may be sufficient to meet its planned expenditures and obligations for at least the one-year period following the issuance of its consolidated financial statements; however, such expectations are subject to significant uncertainty, and substantial doubt remains about the Company’s ability to continue as a going concern.

These consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and the settlement of liabilities in the normal course of business. These consolidated financial statements do not reflect the adjustments to the carrying values of assets and liabilities, the reported revenues and expenses, and the statement of financial position classifications used, that would be necessary if the Company were unable to realize its assets and settle its liabilities as a going concern in the normal course of operations. Such adjustments could be material.