Study of over 2,000 Average-Risk Patients Aims to Validate Mainz Biomed’s Best-in-Class Results in Detecting Advanced Precancerous Lesions (APL) Using Independent Samples

Top-Line Results Expected in the Fourth Quarter of 2025

BERKELEY, Calif., March 27, 2025 — Mainz Biomed N.V. (NASDAQ:MYNZ), a molecular genetics diagnostics firm focused on early cancer detection, announced the enrollment of the first patient in eAArly DETECT 2, a study to assess its next-generation colorectal cancer (CRC) test. The study will enroll approximately 2,000 average-risk patients and will evaluate the test, which combines the company’s mRNA biomarkers, an AI-driven algorithm, and a FIT test, to confirm the positive outcomes of earlier studies and to support shifting CRC screening towards CRC prevention.

Enrollment in the eAArly DETECT 2 study is anticipated to be completed in the latter half of 2025, with top-line results expected by the fourth quarter of 2025. Depending on the study results, Mainz Biomed plans to finalize the protocols for ReconAAsense, its pivotal U.S. study, scheduled to begin in 2026. This advanced CRC and APL test aims to accurately detect cancerous polyps and potentially prevent the disease through early detection of precancerous adenomas.

“The enrollment of the first patient marks the culmination of months of preparation to ensure optimal trial management and the study’s official start,” stated Guido Baechler, CEO of Mainz Biomed. “This trial is particularly exciting for the Company, patients, and medical professionals. By accurately detecting advanced precancerous lesions and early-stage CRC, we seek to advance our goal of eliminating colorectal cancer and reducing global cancer mortality.”

The five novel gene expression (mRNA) biomarkers, acquired from Sherbrooke University in 2022, have shown a notable ability to identify advanced adenomas – treatable precancerous polyps – and early-stage CRC. The eAArly DETECT 2 study will further assess the effectiveness of these biomarkers combined with Mainz Biomed’s algorithm to refine product specifications, expand its ability to identify advanced adenomas, and improve diagnostic sensitivity and specificity for early-stage CRC.

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About Mainz Biomed NV
Mainz Biomed creates molecular genetic diagnostic solutions for life-threatening diseases ready for market. The Company’s main product is ColoAlert®, an accurate, non-invasive, and user-friendly test for the early detection of colorectal cancer. ColoAlert® is sold throughout Europe. The Company is currently performing a development study to finalize the next-generation CRC screening test in preparation for the pivotal FDA clinical study for US regulatory approval. Mainz Biomed’s product pipeline also includes PancAlert, an early-stage pancreatic cancer screening test using real-time Polymerase Chain Reaction-based (PCR) multiplex detection of molecular-genetic biomarkers. For more information, visit or follow us on , and .

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Forward-Looking Statements

This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995. These statements can be identified by terms such as “anticipate”, “believe”, “expect”, “estimate”, “plan”, “outlook”, and “project”, and similar expressions that suggest future events or trends, or that do not relate to historical matters. These forward-looking statements reflect current analysis of existing information and are subject to various risks and uncertainties. Therefore, caution should be taken when relying on them. Actual results may differ significantly from the Company’s expectations or projections due to known and unknown risks. Factors that could cause actual results to differ materially include: (i) failure to achieve projected development targets; (ii) changes in laws or regulations; and (iii) other risks and uncertainties described herein, and those discussed in the Company’s reports and public filings with the Securities and Exchange Commission (the “SEC”). More information about these and other factors that could affect the Company’s expectations and projections can be found in its filings with the SEC, including its annual report on Form 20-F filed on April 9, 2024. The Company’s SEC filings are publicly available on the SEC’s website at www.sec.gov. Any forward-looking statement in this press release is based only on information currently available to Mainz Biomed and speaks only as of its date. Mainz Biomed undertakes no obligation to update any forward-looking statement, whether written or oral, that may be made, except as required by law.

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