Mainz Biomed anticipates releasing interim data by the close of summer 2025.

Top-line data is projected for release in Q4 2025; the trial remains on schedule to facilitate the initiation of a pivotal U.S. study in 2026.

BERKELEY, Calif. and MAINZ, Germany, May 16, 2025 — Mainz Biomed N.V. (NASDAQ:MYNZ), a molecular genetics diagnostics firm focused on early cancer detection, today announced its intention to share interim findings from its eAArly DETECT 2 feasibility study by the end of summer 2025. The study is assessing the company’s next-generation colorectal cancer (CRC) screening test, which combines Mainz Biomed’s exclusive mRNA biomarkers, an AI-driven algorithm, and a FIT test across roughly 2,000 patients at average risk. This evaluation aims to confirm the superior results from prior feasibility studies and to facilitate the shift from CRC screening to CRC prevention.

Enrollment for the eAArly DETECT 2 study is expected to be completed in the latter half of 2025, with the company aiming to publish top-line results by the fourth quarter of 2025. Pending the study’s results, Mainz Biomed plans to finalize its protocols for ReconAAsense, its pivotal U.S. study, which is still slated to begin in 2026. This advanced CRC and APL (Adenomatous Polyps) test aims to accurately identify cancerous polyps and potentially prevent the disease through the early detection of precancerous adenomas.

“We are pleased with the advancements made by the team on eAArly DETECT 2 and are eager to provide an interim update to partners and shareholders, targeting the end of this summer,” stated Guido Baechler, Chief Executive Officer of Mainz Biomed. “This clinical trial is especially significant for the Company, patients, and healthcare professionals. By precisely identifying advanced precancerous lesions and early-stage CRC, we strive to further our goal of eradicating colorectal cancer and, ultimately, decreasing global cancer mortality rates.”

The five novel gene expression (mRNA) biomarkers, acquired from Sherbrooke University in 2022, have shown a distinctive capacity to detect advanced adenomas – treatable precancerous colonic polyps – and early-stage CRC that can be treated. The eAArly DETECT 2 study will further assess and validate the efficacy of these biomarkers when used with Mainz Biomed’s proprietary algorithm to refine product specifications, broaden its ability to include the detection of advanced adenomas, and improve the diagnostic sensitivity and specificity for early-stage CRC.

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About Mainz Biomed NV
Mainz Biomed is dedicated to creating molecular genetic diagnostic solutions ready for the market that address life-threatening diseases. ColoAlert®, the Company’s main product, is a precise, non-invasive, user-friendly diagnostic test for the early detection of colorectal cancer. ColoAlert® is currently sold throughout Europe. The Company is conducting a pivotal FDA clinical study to gain regulatory approval in the US. Mainz Biomed’s pipeline also features PancAlert, an early-stage screening test for pancreatic cancer that uses real-time Polymerase Chain Reaction-based (PCR) multiplex detection of molecular-genetic biomarkers in stool samples. For more information, visit or follow us on , and .

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Certain statements in this press release are “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995’s “safe harbor” provisions. These forward-looking statements encompass details about potential or anticipated future operational results, including statements regarding our clinical trials and studies, business strategies or plans, prospects, future cash flows, financing strategies, management objectives, future cash requirements, and any statements that are not based on historical facts. Forward-looking statements can be identified by terms like “anticipate,” “believe,” “expect,” “estimate,” “plan,” “outlook,” and “project,” alongside similar expressions that forecast or suggest upcoming events or trends, or those that are not statements of historical fact. These forward-looking statements are based on the present analysis of existing information and are subject to various risks and uncertainties. As a result, caution is advised when relying on these statements. Due to both known and unknown risks, actual results might significantly differ 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) failure to achieve projected development and related targets; (ii) changes in relevant laws or regulations; (iii) the impact of the COVID-19 pandemic on the Company and its existing or intended markets; and (iv) other risks and uncertainties detailed herein, as well as those discussed periodically in other reports and public filings with the Securities and Exchange Commission (the “SEC”) by the Company. Further details regarding these and other factors that could affect 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 publicly accessible on the SEC’s website at www.sec.gov. Any forward-looking statement made by us in this press release is based solely on the information available to Mainz Biomed at the time of its making and speaks only as of the date it is made. Mainz Biomed disclaims any obligation to update any forward-looking statement, whether written or oral, that may be issued from time to time, whether due to new information, future developments, or other factors, except as legally required.

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