Mainz Biomed Provides Corporate Update for First Half of 2022
05 July 2022 - 5:01PM
Mainz Biomed N.V. (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”),
a molecular genetics diagnostic company specializing in the early
detection of cancer, is pleased to host a webcast on July 12, 2022
at 4:00pm ET to provide an update on the Company’s progress for the
first half of 2022, and to outline the plan for the balance of the
fiscal year.
The webcast will offer the investment community a comprehensive
briefing by Mainz’s executive management team on the Company’s
flagship product ColoAlert, a highly efficacious, and easy-to-use
detection test for colorectal cancer (CRC) which is being
commercialized internationally through a differentiated business
model of partnering with third-party laboratories for test kit
processing versus the traditional methodology of operating a single
facility. The presentation will also include an update on the
status of ColoAlert’s U.S. regulatory approval pathway, the ongoing
R&D efforts to potentially upgrade ColoAlert’s technical
profile to achieve “gold standard” status for CRC at-home testing,
an overview of additional products in development, and the
Company’s go-forward strategy to facilitate growth.
“Given the progress achieved over the past six months across all
aspects of the company, the management and Board thought it was
appropriate to host this interactive forum to provide an overall
update on progress, especially in light of our recent transition to
the public sector this past November,” commented Guido Baechler,
Chief Executive Officer of Mainz Biomed. “We look forward to
providing a detailed presentation covering ColoAlert’s commercial
execution and clinical development status along with commentary on
the balance of the product development pipeline, and our overall
strategy to become a leading oncology focused diagnostic
company.”
Mainz Biomed - Mid-Year
UpdateConference ID: 13730909Date
and Time: Tuesday July 12, 2022, 4:00 PM ET
To access the webcast, please register HERE
For dial in access, please use the following:Toll
Free: 1-877-269-7751Toll/International:
1-201-389-0908
The Mainz mid-year update will be made available for replay for
14 days after the event.
The webcast replay can be accessed HEREToll
Free: 1-844-512-2921Toll/International:
1-412-317-6671Replay Pin Number:
13730909Replay Start: Tuesday July 12, 2022, 7:00
PM ETReplay Expiry: Tuesday July 26, 2022, 11:59
PM ET
About ColoAlertColoAlert detects colorectal
cancer (CRC) via a simple-to-administer test with a sensitivity and
specificity nearly as high as the invasive colonoscopy*. The test
utilizes proprietary methods to analyze cell DNA for specific tumor
markers combined with the fecal immunochemical test (FIT) and is
designed to detect tumor DNA and CRC cases in their earliest
stages. The product is CE-IVD marked (complying with EU safety,
health and environmental requirements) and is transitioning to
compliance with IVDR. The product is commercially available in a
selection of countries in the European Union. Mainz Biomed
currently distributes ColoAlert through a number of clinical
affiliates. Once approved in the U.S., the Company’s commercial
strategy is to establish scalable distribution through a
collaborative partner program with regional and national laboratory
service providers across the country.*Dollinger MM et al.
(2018)
About Colorectal CancerColorectal cancer (CRC)
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%. Annual testing costs per patient are minimal, especially
when compared to late-stage treatments of CRC which cost patients
an average of $38,469 per year. The American Cancer Society
estimated that in 2021 there were approximately 149,500 new cases
of colon and rectal cancer in the U.S. with 52,980 resulting in
death. Recent FDA decisions suggest that screening with stool DNA
tests such as ColoAlert in the US should be conducted once every
three years starting at age 45. Currently, there are 112 million
Americans aged 50+, a total that is expected to increase to 157
million within 10 years. Appropriately testing these US-based 50+
populations every three years as prescribed equates to a US market
opportunity of approximately $3.7 Billion per year.
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. ColoAlert is
currently marketed across Europe with FDA clinical study and
submission process intended to be launched in the first half of
2022 for U.S. regulatory approval. Mainz Biomed’s product candidate
portfolio includes PancAlert, an early-stage pancreatic cancer
screening test based on Real-Time Polymerase Chain Reaction-based
(PCR) multiplex detection of molecular-genetic biomarkers in stool
samples, and the GenoStick technology, a platform being developed
to detect pathogens on a molecular genetic basis.
For more information, please visit
www.mainzbiomed.com
For media enquiries, please
contact press@mainzbiomed.com
For investor enquiries, please
contact ir@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 registration statement on Form
F-1 filed on January 21, 2022. 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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