Mainz Biomed Provides Half Year 2024 Corporate Update

Issuer: Mainz BioMed N.V. / Key word(s): Half Year Results
Mainz Biomed Provides Half Year 2024 Corporate Update

02.07.2024 / 14:01 CET/CEST
The issuer is solely responsible for the content of this announcement.

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Mainz Biomed Provides Half Year 2024 Corporate Update

Industry Leading Clinical Data Position the Company for FDA Premarket
Approval Study

BERKELEY, US - MAINZ, Germany - July 2, 2024 - Mainz Biomed N.V. (NASDAQ:
MYNZ), a molecular genetics diagnostic company specializing in the early
detection of cancer, today reviewed its major accomplishments of the first
six months ending June 30, 2024, and provided a corporate update. The
Company expects to release its half year financial results in September
2024.

Key Highlights During First Half 2024

  * Mainz Biomed presented industry leading results of its pooled study at
    ASCO 2024; which confirmed the 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; the results
    from the pooled study represents the third consecutive confirmation of
    the consistently good performance of Mainz Biomed's mRNA biomarkers to
    detect CRC and precancerous lesions

  * Mainz Biomed was awarded a Poster of Distinction at Digestive Disease
    Week presenting data from its eAArly DETECT study, positioning the
    Company for its planned FDA trial; the poster presented industry leading
    results: 97% sensitivity for colorectal cancer, 82% for advanced
    precancerous lesions; the study demonstrated that within the advanced
    precancerous lesion patients, 100% of those patients with high grade
    dysplasia were detected

  * The Company participated in the 39th UDH Congress 2024, in Fellbach,
    Germany. One of the main focus topics for this year's event, organized
    by the German Complementary Medicine Association (Union Deutscher
    Heilpraktiker, Landesverband Baden-Württemberg), was the gut and its
    significance in the manifestation of diseases

  * Mainz Biomed participated and exhibited at the esteemed Gynecology
    Congress ('Gynäkologie und Geburtshilfe aktuell') in Stuttgart, Germany.
    This engagement signifies the Company's commitment to advancing
    colorectal cancer screening through their innovative diagnostic solution
    ColoAlert® and highlights the pivotal role of gynecologists in the early
    detection of this prevalent disease

  * The Company continues to make strong progress in the development of
    strategic partners to assist in the Mainz Biomed's efforts to achieve
    pre-market approval from the FDA and in its go-to-market strategy in the
    U.S.

  * Mainz Biomed partnered with Trusted Health Advisors to support its U.S.
    go-to-market strategy for the next generation early colorectal cancer
    diagnostic test; Jay Wohlgemuth, former Chief Medical & Scientific
    Officer of Quest Diagnostics and Dr. Ray Tabibiazar, a seasoned industry
    executive, are leading the collaboration

  * The Company formed a strategic partnership with TomaLab, a premier
    biotechnology laboratory based in Milan, to launch the Company's
    flagship product, ColoAlert® in Italy. The partnership signifies a major
    step forward in enhancing colorectal cancer screening and diagnostics
    within the Italian healthcare system as it enables the implementation of
    ColoAlert® into Italy's robust healthcare framework, providing patients
    with access to a cutting-edge diagnostic solution that combines
    convenience with clinical excellence

"I'm extremely pleased with the progress achieved during the first half of
2024 as we execute our ambitious corporate growth strategy driven by our
incredible clinical results in three studies published so far this year,"
commented Guido Baechler, Chief Executive Officer of Mainz Biomed "We head
into the second half of 2024 with a great deal of momentum as we plan for
the beginning of enrollment planning for the ReconAAsense U.S. FDA pivotal
CRC study."

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

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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:    1937999

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