Accelerating FDA Pathway for NextGen Colorectal Cancer Screening and Expansion with Pancreatic Cancer Screening Acquisition

Mainz Biomed Half Year 2025 Update: Accelerating FDA Pathway for NextGen Colorectal Cancer Screening and Expansion with Pancreatic Cancer Screening Acquisition

Company Advances its Progress toward FDA Premarket Approval Study for its Next Generation Colorectal Cancer Screening Product and Makes a Strategic Acquisition in the Field of Pancreatic Cancer Screening

BERKELEY, US – MAINZ, Germany – July 15, 2025 — Mainz Biomed N.V. (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”), a molecular genetics diagnostic company specializing in the early detection of cancer, today reviewed its major accomplishments of the first six months ending June 30, 2025, and provided a corporate update. The Company expects to release its half year financial results in September 2025.

Key Highlights During First Half 2025

• Mainz Biomed launched eAArly DETECT 2, a US feasibility study to evaluate the Company’s next generation colorectal cancer (CRC) test, integrating its proprietary mRNA biomarkers, AI developed algorithm and FIT test, over a population of approximately 2,000 patients, all of average risk, to validate the leading results of previous feasibility studies, which included average risk and identified risk patients.
• The Company entered into a strategic partnership with labor team w ag, a renowned diagnostic laboratory based in Goldach, Switzerland. This collaboration introduces ColoAlert®, a DNA-based colorectal cancer screening test to the Swiss market for the very first time, marking Mainz Biomed’s initial footprint in Switzerland.
• Mainz Biomed entered into a technology partnership with UK-based EDX Medical Group plc, which develops innovative digital diagnostic products and services supporting personalized treatments for cancer, cardiovascular and infectious diseases. Under the agreement, EDX Medical will access the Company’s molecular diagnostic technology as part of the expansion of its portfolio of products for sale in the UK.
• Mainz Biomed entered into a License and Option Agreement with Liquid Biosciences (“Liquid”) to access a portfolio of novel mRNA biomarkers for the non-invasive detection of pancreatic cancer with a blood test. The parties, under the Agreement, plan to develop this blood-based test for potential future FDA applications. The discovery process included multiple independent pancreatic cancer study cohorts. Liquid used their proprietary EMERGE platform to identify a panel of clinically relevant mRNA biomarkers from a blood-based cohort of 285 subjects with 35 pancreatic cancer patients. In the analysis, the biomarkers coupled with the proprietary algorithm developed by Liquid achieved overall sensitivity of 95% and a 98% specificity for the detection of pancreatic cancer. If the statistical results are replicable after the integration into a new product, it has the potential to ultimately position Mainz Biomed’s test to be the most robust and accurate screening test for pancreatic cancer on the market.
• The Company announced the commencement of the next phase in its PancAlert project, a research initiative focused on developing a non-invasive blood-based screening test for the early detection of pancreatic cancer. The feasibility phase is intended to confirm the discovery analysis performed in early 2025 in partnership with Liquid Biosciences which demonstrated sensitivity of 95% with specificity of 98% for the detection of pancreatic cancer in blood samples.
• Mainz Biomed announced that its pancreatic cancer project will receive public funding from the Investitions- und Strukturbank Rheinland-Pfalz (ISB), the development bank of the German federal state of Rheinland-Pfalz. Under the ISB’s Innovation and Technology Support Program (Innovations- und Technologieförderungsprogramm), the state will fund up to 50% of the project’s total costs. This direct governmental support represents a strong endorsement of the scientific and societal value of the Company’s non-invasive, blood-based screening test for the early detection of pancreatic cancer and will accelerate its development.
• The Company received formal notice from The Nasdaq Stock Market LLC (“Nasdaq”) confirming that it has regained compliance with the minimum stockholders’ equity requirement for continued listing on the Nasdaq Capital Market set forth in Listing Rule 5550(b)(1). Mainz Biomed had previously received confirmation that it had regained compliance with the minimum bid price requirement set forth in Nasdaq Listing Rule 5550(a)(2). The Company is now in full compliance with all Nasdaq continued listing requirements and will continue to be listed and traded on The Nasdaq Capital Market.
• Mainz Biomed priced a follow-on offering of 2,000,000 units, with each unit consisting of one ordinary share (or pre-funded warrant in lieu thereof), one Series A warrant (five-year life) to purchase one ordinary share, and one Series B warrant (one-year life) to purchase one ordinary share for gross proceeds of approximately $4.0 million. Each unit was sold at an effective offering price of $2.00 per unit.

“I’m extremely pleased with the progress achieved during the first half of 2025 as we execute our ambitious growth strategy driven by our eAArly DETECT 2 study and advancements of our pancreatic cancer screening program,” commented Guido Baechler, Chief Executive Officer of Mainz Biomed “We head into the second half of this year with a great momentum as we plan for the completion of our eAArly DETECT 2 feasibility study which will be the launching point for the ReconAAsense US FDA pivotal colorectal cancer study in 2026.” 

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®, an accurate, non-invasive and easy-to-use, early-detection diagnostic test for colorectal cancer. ColoAlert® is marketed across Europe and the United Arab Emirates. The Company is currently running 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

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Maximilian Schur / Simone Neeten
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For investor inquiries, please contact ir@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 March 31, 2025. 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.