Mainz Biomed Presented Industry Leading Results of its Pooled Study at ASCO
2024

Issuer: Mainz BioMed N.V. / Key word(s): Study results/Conference
Mainz Biomed Presented Industry Leading Results of its Pooled Study at ASCO
2024

03.06.2024 / 14:01 CET/CEST
The issuer is solely responsible for the content of this announcement.

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Mainz Biomed Presented Industry Leading Results of its Pooled Study at ASCO
2024

New study data confirmed previous ColoFuture and eAArly DETECT study
performance with sensitivity for CRC of 92% and 82% for advanced adenomas,
including 95.8% detection of high-grade dysplasia

Results from pooled study represents the third consecutive confirmation of
the consistently good performance of Mainz Biomed's mRNA biomarkers to
detect CRC and precancerous lesions

BERKELEY, US - MAINZ, Germany - June 3rd, 2024 - Mainz Biomed N.V. (NASDAQ:
MYNZ), a molecular genetics diagnostic company specializing in the early
detection of cancer, presented pivotal data from its largest cohort to date
during a poster presentation at the American Society of Clinical Oncology
(ASCO) 2024 Annual Meeting in Chicago, Illinois, and online. This data
combines results from the ColoFuture and eAArly DETECT studies including
additional patients collected since the first reported study results,
demonstrating the significance of its innovative screening approach.

The combined analysis involves 690 clinical subjects from 30 specialized
gastroenterology centers across Europe and the United States, including
previously unexamined and unreported samples, highlighting the remarkable
efficacy of Mainz Biomed's multimodal screening test. This test integrates
the Fecal Immunochemical Test (FIT) with proprietary mRNA biomarkers,
complemented by an advanced AI and machine learning algorithm. This
combination enables precise differentiation among colorectal cancer (CRC),
advanced adenomas (AA), non-advanced adenomas, and samples with no
pathological findings.

Presentation Details

Title: "A Novel, Non-Invasive, Multimodal Screening Test for Early Detection
of Precancerous Lesions and Colorectal Cancer Using an Artificial
Intelligence-Based Algorithm."

Presenter: Dr. D. Kim Turgeon
Abstract #: 3627
Poster Bd #: #290
Citation: J Clin Oncol 42, 2024 (suppl 16; abstr 3627)

Key Findings

  * Sensitivity for Colorectal Cancer: 92.3% (95% confidence interval:
    84.0-97.1)

* Specificity: 90.1% (95% confidence interval: 87.1-92.7)

  * Sensitivity for Advanced Precancerous Lesions: 82.2% (95% confidence
    interval: 75.0-88.0)

* High-Grade Dysplasia Detection Rate: 95.8%

This study highlighted the significant advantage of the multimodal screening
test over existing methods, particularly in detecting advanced precancerous
lesions. For example, the sensitivity for detecting high-grade dysplasia,
which have an increased risk of turning into cancer, with the multimodal
approach was 95.8%, significantly higher than other non-invasive tests
currently available.

"These results offer the unique promise of a self-administered screening
tool with highly effective detection of adenomas (AA), a type of
pre-cancerous polyp often attributed to this deadly disease," commented Dr.
Kim Turgeon, M.D., Professor of Gastroenterology and Internal Medicine at
University of Michigan Health. "Patients with advanced adenomas have an
increased risk of developing colorectal cancer. The significant improvement
in AA sensitivity compared to other non-invasive tests currently available,
allows for the screening paradigm to shift from cancer detection to
prevention. I believe that these results are very promising for the GI
community."

Dr. Moritz Eidens, Chief Scientific Officer at Mainz Biomed, commented,
"Combining data from two different studies to achieve these outstanding
results is highly unusual and demonstrates the robustness of our multimodal
screening test. It is also the third consecutive read-out of scientific data
that confirms the ability of our innovative test: The significant
improvement in sensitivity for advanced adenomas, combined with high
sensitivity and specificity for CRC, supports our mission to transform
colorectal cancer screening practices and reduce global cancer mortality
rates."

For more detailed results, visit
https://mainzbiomed.com/wp-content/uploads/2024/05/ASCO_MBM_poster.pdf to
access the poster with the detailed results.

Please visit Mainz Biomed's official website for investors at
mainzbiomed.com/investors/ for more information.

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About eAArly DETECT and ColoFuture

eAArly DETECT and ColoFuture studies were designed to integrate novel mRNA
biomarkers into Mainz Biomed's pivotal FDA PMA clinical trial ReconAAsense.
The studies included 690 evaluable subjects across 21 sites in the U.S. and
9 sites in Europe. The two cohorts included patients (US cohort aged 45 and
older and European cohort aged 40 and older) that provided a stool sample
before undergoing a colonoscopy to either screen for CRC (average risk), to
follow up on a positive non-invasive test, imaging or symptoms, or if a
subject was already identified as having colorectal cancer but before any
treatment had been administered. 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.

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 planning to run 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. To learn more, visit
mainzbiomed.com.

For media inquiries

MC Services AG
Anne Hennecke/Caroline Bergmann
+49 211 529252 20
mainzbiomed@mc-services.eu

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 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.


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   Language:       English
   Company:        Mainz BioMed N.V.
                   Robert-Koch-Strasse 50
                   55129 Mainz
                   Germany
   Internet:       mainzbiomed.com
   EQS News ID:    1915557

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