BERKELEY, Calif., April 28, 2025 — Mainz Biomed N.V. (NASDAQ: MYNZ), a company focused on molecular genetics diagnostics for early cancer detection, today reported its key achievements for the first three months of 2025 and outlined its strategy for securing FDA premarket approval.

Key highlights from Q1 2025:

• FDA premarket approval pathway: The first patient has been enrolled in the company’s eAArly DETECT 2 feasibility study. This study is assessing Mainz Biomed’s advanced colorectal cancer (CRC) test, which combines a range of its own mRNA biomarkers, an AI algorithm, and a FIT test. Around 2,000 average-risk individuals are expected to participate in the study to confirm the strong results from earlier feasibility studies and to facilitate a shift in CRC screening toward prevention. With the enrollment of the first patient, the company remains on track to release top-line results by the end of 2025.
• Mainz Biomed entered into a license and option agreement with Liquid Biosciences, securing access to innovative mRNA biomarkers for the early detection of pancreatic cancer through a blood test. Independent validation of the biomarker-algorithm combination demonstrated 95% sensitivity and 98% specificity.
• The company formed a strategic alliance with labor team w ag, a well-known diagnostics laboratory based in Goldach, Switzerland. This partnership marks Mainz Biomed’s entry into the Swiss market with the introduction of ColoAlert^®, a DNA-based CRC screening test. Given the thousands of new cases diagnosed in Switzerland each year, there’s a critical need for early detection and prevention. The launch of a DNA-based CRC screening test presents an opportunity to improve participation rates and ensure early detection, which supports national efforts to lower CRC-related deaths and improve public health.
• Mainz Biomed announced the official launch of the enhanced ColoAlert CRC screening test by GANZIMMUN Diagnostics. Since January 2025, patients throughout Germany have had access to the updated version of the company’s screening test. The announcement coincided with Colorectal Cancer Awareness Month in March.
• On January 23, 2025, Nasdaq formally notified the company that it had regained compliance with the minimum stockholders’ equity requirement for continued listing on the Nasdaq Capital Market, as specified in Listing Rule 5550(b)(1). Mainz Biomed had previously confirmed its compliance with the minimum bid price requirement outlined in Nasdaq Listing Rule 5550(a)(2). Mainz Biomed is now fully compliant with all Nasdaq continued listing requirements.

“I am very happy with the progress made during the first quarter of 2025 as we implement our strategy, which is informed by the excellent clinical results from three studies published in 2024,” stated Guido Baechler, Chief Executive Officer of Mainz Biomed. “Our eAArly DETECT 2 study, with results expected by the end of 2025, is crucial for enabling us to quickly begin enrolling patients in our pivotal U.S. FDA study, ReconAAsense, shortly thereafter.”

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About Mainz Biomed NV
Mainz Biomed specializes in developing ready-to-market molecular genetic diagnostic solutions for life-threatening diseases. Its primary product, ColoAlert^®, is a precise, non-invasive, and user-friendly diagnostic test for the early detection of colorectal cancer. ColoAlert^® is currently available across Europe. The company is conducting a development study to finalize its next-generation CRC screening test in preparation for the pivotal FDA clinical study required for US regulatory approval. Mainz Biomed’s pipeline also includes PancAlert, an early-stage pancreatic cancer screening test that utilizes real-time Polymerase Chain Reaction-based (PCR) multiplex detection of molecular-genetic biomarkers. For additional information, please 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’s “safe harbor” provisions. These statements can be identified by terms such as “anticipate,” “believe,” “expect,” “estimate,” “plan,” “outlook,” “project,” and similar expressions that predict or suggest future events or trends, and which are not statements of historical fact. These forward-looking statements reflect the current analysis of existing information and are subject to various risks and uncertainties. Therefore, caution should be exercised when relying on them. Actual results may differ materially 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 meet projected development and related targets; (ii) changes in applicable laws or regulations; and (iii) other risks and uncertainties detailed herein, as well as those discussed periodically in the Company’s other reports and public filings with the Securities and Exchange Commission (the “SEC”). Further information regarding these and other factors that may 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 March 31, 2025. The Company’s SEC filings are publicly available on the SEC’s website at www.sec.gov. Any forward-looking statement made by us in this press release is based solely on information available to Mainz Biomed as of the date it is made and speaks only as of that date. Mainz Biomed undertakes no obligation to 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.