Mainz Biomed N.V. announced groundbreaking topline results from a pooled clinical study which included new patients and subjects from Mainz Biomed's ColoFuture (Europe) and eAArly DETECT (U.S.) clinical trials evaluating the potential to integrate its portfolio of proprietary novel gene expression (mRNA) biomarkers into a next generation version of the Company's colorectal cancer (CRC) screening tool. The topline results confirm the positive efficacy results previously reported with a sensitivity for colorectal cancer of 92% with a specificity of 90% and a sensitivity for advanced adenoma of 82%, which is best-in-class and compare favorably to existing commercial products. The pooled results include 690 evaluable subjects across 21 sites in the U.S. and 9 sites in Europe.

Following colonoscopy and any applicable histopathology, subjects were classified into groups: CRC, advanced adenoma, non-advanced adenoma, no findings, or non-colorectal cancer. Each subject outcome was compared to the results from the next generation test incorporating the novel mRNA biomarkers and FIT. The Company plans to publish results of this study at a major medical conference during the second quarter of 2024.

According to the Centers for Disease Control and Prevention (CDC), colorectal cancer is the second most lethal cancer in the U.S., and Europe, but also the most preventable, with early detection providing survival rates above 90%. In the landscape of early colon cancer diagnostics with non-invasive tests, stool-based screening methods proved to be the most precise. Subject to a positive outcome of the FDA PMA study, Mainz Biomed's innovative next generation test has the potential to disrupt the at-home CRC diagnostic screening market by providing the most robust and accurate test and become new gold standard.

Based on PCR-technology, ColoAlert®? detects more cases of colorectal cancer than other stool tests and allows for an earlier diagnosis (Dollinger et al., 2018, Franck et al. 2024).

The product is commercially available in select EU countries through a network of leading independent laboratories, corporate health programs and via direct sales. To receive marketing approval in the US, ColoAlert®? will be evaluated in the FDA-registration trial 'ReconAAsense'.

Once approved in the US, the Company's commercial strategy is evaluating the potential to incorporate the mRNA biomarkers and FIT and a proprietary AI algorithm for integration into the next generation clinical trial for next generation cancer. The company plans to published results of this study at a large medical conference during the second quarter the second quarter of 2024. The product is commercially available inselect EU countries through a network ofleading independent laboratories, corporate health programs, direct sales.

To receive marketing approved in the US, Colo Alert®? will be evaluated in The FDA-registration trial ' ReconAAsense'. Once approval in the US, the company's commercial strategy is evaluating the product's commercial strategy is evaluating potential potential to integrate the potential to integrate the novel mRNA biomarkers, FIT test, and a proprietary AI Algorithm.