Mainz Biomed Provides Review of 2025 Highlights

Mainz Biomed Provides Review of 2025 Highlights

Initiation of eAArly DETECT 2 - U.S. Clinical Study to Evaluate Performance of Next Generation Test on Advanced Adenomas over Large Patient Population in Preparation for ReconAAsense U.S. FDA Pivotal Trial

Results from Feasibility Study of Biomarker Panel in Pancreatic Cancer Project Study Demonstrated a Sensitivity of 100% and Specificity of 95%

BERKELEY, US – MAINZ, Germany – January 5, 2026 — 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 for the year ended December 31, 2025. The Company expects to release its year-end financial results in March 2026.

Key Highlights During 2025

Colorectal Cancer Business Highlights

• 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.
• ColoAlert®, the Company’s DNA-based colorectal cancer (CRC) screening test, received official registration with the Medicines and Healthcare products Regulatory Agency (MHRA) and is now authorized for marketing in the United Kingdom.
• ColoAlert® has also been officially registered and approved for distribution by Swissmedic, the Swiss regulatory and supervisory authority for medicinal products and medical devices.
• 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 signed a Memorandum of Understanding (“MOU”) with OncoVanguard8, a distributor of oncological innovations. The collaboration aims to introduce ColoAlert® to South America, starting with Peru.
• Mainz Biomed collaborated with CARE diagnostica Laborreagenzien GmbH (“CARE”). CARE is currently working with more than 15 statutory health insurance companies as part of special online-based screening concepts based on the widely used fecal immunochemical test (FIT). Thanks to the cooperation with Mainz Biomed, the range of services for risk groups could potentially be expanded to include the ColoAlert® test, which uses molecular genetic analysis of biomarkers in stool using PCR to increase the detection rate, particularly in the early stages of the disease.
• Mainz Biomed also announced that ColoAlert® has been added to the portfolio of DoctorBox, one of Germany’s leading pioneers in digital health. This marks another important milestone in Mainz Biomed’s European growth strategy and highlights the increasing importance of innovative, personalized solutions in preventive medicine. Laboratory analysis will be performed by Mainz Biomed’s long-standing partner, the European Oncology Lab, led by Dr. med. Annette Buhlmann in St. Ingbert, Germany.

Pancreatic Cancer Business Highlights

• In March 2025 the Company 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.
• In October 2025 the Company announced positive topline results from its feasibility study, examining a non-invasive blood-based screening test for the early detection of pancreatic cancer, initiated earlier in 2025. The study confirmed the strong clinical accuracy and utility of licensed proprietary biomarkers from Liquid Biosciences for developing an innovative screening test for pancreatic cancer. Researchers evaluated 18 licensed biomarkers across multiple candidate panels to streamline assay complexity. The leading panel achieved 100% sensitivity and 95% specificity, successfully distinguishing pancreatic cancer patients from healthy controls in a 30-subject cohort, reflecting different stages of the disease as well as precursors.
• 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.

“I’m extremely pleased with the achievements of our team during 2025 as we advance our ambitious growth strategy, driven by our eAArly DETECT 2 study and continued progress in our pancreatic cancer screening program,” commented Guido Baechler, Chief Executive Officer of Mainz Biomed. “Looking ahead to the first half of 2026, we expect to complete our eAArly DETECT 2 feasibility study, which will be the launching point for our ReconAAsense US FDA pivotal colorectal cancer study in 2026, and to announce our next steps in advancing our blood-based screening test for the early detection of pancreatic cancer.”

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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. The Company is currently running its eAArly DETECT 2 clinical study in preparation for its pivotal FDA 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 blood and stool samples. To learn more, visit mainzbiomed.com or follow us on LinkedIn, Twitter and Facebook.

For media inquiries as to Mainz Biomed:

MC Services AG
Maximilian Schur / Simone Neeten
+49 211 529252 20
mainzbiomed@mc-services.eu

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 and its mid-year report on Form 6-K filed on September 26, 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.