Mainz Biomed Announces Interim Read Out For Its eAArly DETECT 2 Clinical Study
Company intends to provide an interim read out by the end of summer 2025
Top-line results anticipated in Q4 2025; study on track to support U.S. pivotal trial initiation in 2026
BERKELEY, Calif. and MAINZ, Germany, May 16, 2025 (GLOBE NEWSWIRE) -- Mainz Biomed N.V. (NASDAQ:MYNZ) ("Mainz Biomed" or the "Company"), a molecular genetics diagnostic company specializing in the early detection of cancer, announced today that it intends to provide an interim read out of its eAArly DETECT 2 feasibility study by the end of summer 2025. The study is evaluating the Company's next-generation colorectal cancer (CRC) screening test that integrates Mainz Biomeds proprietary mRNA biomarkers, an AI-developed algorithm, and a FIT test over a population of approximately 2,000 average-risk patients to validate the industry-leading results of previous feasibility studies and support the transition of CRC screening to CRC prevention.
The eAArly DETECT 2 study is expected to complete enrollment in the second half of 2025, and the Company targets reporting top-line results by the fourth quarter of 2025. Based on the study's outcome, Mainz Biomed intends to finalize its protocols for ReconAAsense, the Company's U.S. pivotal study, which is on track to initiate in 2026. This next-generation CRC and APL (Adenomatous Polyps) test will not only detect cancerous polyps with a high degree of accuracy but can potentially prevent the disease through early detection of precancerous adenomas.
"We are excited about the progress the team has been making on eAArly DETECT 2 and look forward to providing partners and shareholders an interim update, targeted for the end of this summer," commented Guido Baechler, Chief Executive Officer of Mainz Biomed. "This clinical trial is particularly exciting for the Company, the patient community, and the medical professionals alike. By precisely detecting advanced precancerous lesions and early-stage CRC, we aim to advance our mission of eliminating colorectal cancer and ultimately reducing global cancer mortality rates."
The five novel gene expression (mRNA) biomarkers, which the Company acquired from Sherbrooke University in 2022, have demonstrated a unique ability to identify advanced adenomas – curable precancerous colonic polyps – as well as treatable early-stage CRC. The eAArly DETECT 2 study will further evaluate and confirm the effectiveness of these biomarkers combined with Mainz Biomed's proprietary algorithm to enhance product specifications, extending its capability to include the identification of advanced adenomas while increasing rates of diagnostic sensitivity and specificity for early-stage CRC.
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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 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.
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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. These forward-looking statements include information concerning possible or projected future results of our operations, including statements about our clinical trials and studies, business strategies or plans; prospects; future cash flows; financing plans; objectives of management; future cash needs; and any other statements that are not historical facts. 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 April 9, 2024. 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.
