Full Press Release Details
Mainz Biomed's ColoFuture Study, Evaluating
its Novel mRNA Biomarkers, Reports Groundbreaking
Topline Results Demonstrating Sensitivity for Colorectal Cancer of 94% with Specificity
Advanced Adenoma Sensitivity of 81%
Multiple novel mRNA biomarkers identified
for potential integration into pivotal FDA PMA clinical trial
BERKELEY, US - MAINZ, Germany -
September 13, 2023 - 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 positive topline results from its ColoFuture
study. The ColoFuture study is a multi-center international clinical trial assessing the potential to integrate a portfolio of novel gene
expression (mRNA) biomarkers into ColoAlert , the Company's highly efficacious, and easy-to-use screening test for
colorectal cancer (CRC) which is being commercialized across Europe and in select international territories. The results of this groundbreaking
study included sensitivity for colorectal cancer of 94% with a specificity of 97% and a sensitivity for advanced adenoma of 81%
"The data generated from the ColoFuture
study exceeded our expectations. As we look forward to publishing and presenting the full dataset at a forthcoming medical conference,
we eagerly await the outcome from our eAArly DETECT clinical trial which remains on track to report
results in Q4 of this year," commented Guido Baechler, Chief Executive Officer of Mainz Biomed.
of mRNA biomarkers evaluated in the ColoFuture study was acquired from the Universit de Sherbrooke (January 2022) to
potentially enhance ColoAlert 's technical profile to further extend its capability to include the identification
of advanced adenomas (AA), a type of pre-cancerous polyp often attributed to CRC, and to increase the diagnostic sensitivity and specificity
rates for CRC. In Sherbrooke's pioneering work, researchers tested a battery of novel transcriptional
mRNA biomarkers using samples obtained from patients diagnosed with CRC or as having an advanced adenoma and identified a subset of mRNA
biomarkers that provided the greatest sensitivity and specificity of detection (Herring et al. 2021). Mainz Biomed specifically selected
those mRNA 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 advanced adenomas. The power to detect
lesions in a pre-cancerous stage can change the entire CRC diagnostic landscape. If advanced adenomas are identified early, they are curable.
By treating the patient before the polyps can progress to a cancerous stage, CRC can be prevented.
is an international clinical study evaluating the performance of the Mainz Biomed Colorectal Cancer Screening Test. This test is a combination
of the ColoAlert test and novel mRNA markers. COLOFUTURE includes subjects aged 40-85 from participating centers in Germany, Norway and
Denmark. Subjects are invited to participate in the study either when referred for colonoscopy (screening or diagnostic) or if already
diagnosed with colorectal adenocarcinoma but treatment naive. To be included, subjects provide informed consent and submit samples
from one stool collection prior to colonoscopy or treatment. Completed subjects are placed into one of the following groups based on the
colonoscopy results and any applicable pathology report from biopsy: colorectal adenocarcinoma, advanced precancerous lesions in the colon
or rectum, non-advanced adenoma, or normal. Each subject's stool sample is tested with the Mainz Biomed Colorectal Cancer Screening
Test. The primary endpoints of the study are to determine sensitivity and specificity for colorectal adenocarcinoma. There are multiple
secondary and exploratory endpoints including determining sensitivity and specificity for advanced precancerous lesions in the colon.
The interim analysis included 220 subjects.
ColoAlert , Mainz Biomed's
flagship product, delivers high sensitivity and specificity in a user-friendly, at-home colorectal cancer (CRC) screening kit. This non-invasive
test can be indicative of tumors as determined by analyzing tumor DNA, offering better early detection than fecal occult blood tests
(FOBT). 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). 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 to establish scalable distribution through a collaborative partner program with regional and national laboratory service providers
About Colorectal Cancer
Colorectal cancer (CRC)
is the third most common cancer globally, with more than 1.9 million new cases reported in 2020, according to World Cancer Research Fund
International. The US Preventive Services Task Force recommends that screening with stool DNA tests such as ColoAlert should
be conducted once every three years starting at age 45. Each year in the US, 16.6 million colonoscopies are performed. However, roughly
one-third of US residents aged 50-75 have never been screened for colon cancer. This gap in screening represents a $4.0B+ total market
opportunity in the US.
About Mainz Biomed N.V.
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 based on real-time Polymerase Chain Reaction-based (PCR) multiplex
detection of molecular-genetic biomarkers in stool samples. ColoAlert is currently marketed across Europe. The Company is running
a pivotal FDA clinical study for US regulatory approval. Mainz Biomed's product candidate portfolio also includes PancAlert, an
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Anne Hennecke/Caroline Bergmann
For investor inquiries, please contact info@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 April 7, 2023. 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.