Mainz Biomed Reports Positive Results from Feasibility Study Evaluating its

• Mainz Biomed’s proprietary nucleic acid extraction and PCR process proved to be highly effective

• Two mRNA biomarkers found to be particularly valuable in detecting disease signals in advanced adenoma samples

• eAArly DETECT clinical trial evaluating these biomarkers with fresh samples reporting results mid-year 2023

• Results of eAArly DETECT will inform possible inclusion in U.S. Pivotal Clinical Trial (ReconAAsense) assessing Company’s CRC detection test

• ReconAAsense represents an opportunity to achieve gold standard status for self-administered colorectal cancer (CRC) screening

BERKELEY, Calif. and MAINZ, Germany, March 29, 2023 (GLOBE NEWSWIRE) — Mainz Biomed NV (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”), a molecular genetics diagnostic company specializing in the early detection of cancer, announced today results of an independent feasibility study conducted in collaboration with members of the Early Detection Research Network (EDRN) to evaluate the Company’s portfolio of five novel gene expression (mRNA) biomarkers acquired from Université de Sherbrooke in January, 2022.

Data results highlights from this feasibility study include:

• Mainz’s proprietary nucleic acid extraction process and PCR process is robust and highly reliable – able to consistently obtain DNA and mRNA from patient specimens that were stored for greater than 15 years

• Two mRNA biomarkers proved powerful in detecting disease signals from these aged specimens

  • Able to detect signals from samples of known colorectal cancer (CRC) patients deemed to have higher levels of CRC-specific transcripts, and from specimens of AA patients where disease is in the early stage and thus CRC-specific transcripts are fewer and harder to detect

  • In univariate analysis, demonstrated statistically significant differences between:

    • CRC specimens and controls p=0.0002 and p=0.001, respectively and more importantly,

    • Advanced adenoma (AA) specimens and controls p=0.0005 and p=0.07 (trend), respectively

Story continues

“I am extremely pleased with the study’s result as this outcome is exactly what the Mainz team envisioned when acquiring this portfolio of biomarkers, as it is well documented in the medical community that accurate and early detection of CRC and precancerous adenomas plays an integral role in saving lives,” commented Guido Baechler, Chief Executive Officer of Mainz Biomed. “We now await the mid-year 2023 results of our eAArly DETECT clinical trial evaluating these biomarkers prospectively with fresh, stabilized samples from enrolled patients versus frozen stool samples from up to 15 years ago. We are keen to review the composite of results from both studies to determine which biomarkers are finally selected for integration into our ReconAAsense U.S. pivotal trial for PMA approval. With a way to diagnose both CRC and AA, Mainz has the potential to transform self-administered CRC screening by bringing to market the best-in-class diagnostic test.”

In Sherbrooke’s pioneering work, researchers tested a battery of novel transcriptional biomarkers using samples obtained from patients diagnosed with CRC or as having an advanced adenoma (“AA”), a type of precancerous polyp, and identified a subset of mRNA biomarkers that provided the greatest sensitivity and specificity of detection (Herring et al. 2021). Mainz specifically selected those RNA biomarkers which demonstrated not just the ability to detect a disease signal from samples of patients who were known to have colorectal cancer, but also the unique potential to identify a signal from samples of patients with AA. The power to detect a disease signal in samples from patents with AA can change the entire CRC diagnosis landscape because AA often progresses to CRC, but if treated at the appropriate time AA is curable, CRC can be prevented.

Knowing how fragile mRNA can be, all of Sherbrooke’s research on the mRNA biomarkers was performed using fresh and retrospective stool samples allowing for high quality mRNA extraction, and best-in-class RT-PCR. However, real world CRC testing is often performed with suboptimal patient specimens. Therefore, as part of this feasibility analysis of the “Sherbrooke biomarkers,” the Company utilized banked frozen stool samples provided by the Great Lakes-New England Clinical and Validation Center (GLNE CVC) of the Early Detection Research Network (EDRN). The GLNE includes investigators at several top-tier medical centers including MD Anderson…