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 operational results for the
first quarter ended March 31, 2022.
Key Highlights
- Continued to ramp up EU commercial activities for ColoAlert,
the Company’s highly efficacious, and easy-to-use detection test
for colorectal cancer
- Acquired portfolio of novel mRNA biomarkers to potentially
upgrade ColoAlert’s technical profile to achieve “gold standard”
status for CRC at-home testing
- Commenced international clinical study (ColoFuture) to evaluate
integration of these biomarkers into ColoAlert
- Received supportive feedback from the U.S. Food and Drug
Administration (FDA) on ColoAlert’s pre-submission package for its
U.S. pivotal clinical trial
- Formally initiated ColoAlert’s U.S. medical reimbursement
process with the Centers for Medicare Services (CMS)
- Executed a $25.8 million public follow-on offering
- Expanded Strategic Advisory Board of global leaders in
molecular diagnostic development and commercialization
“This past quarter has proven to be an excellent period of
progress across commercial, corporate and product development
fronts,” commented Guido Baechler, Chief Executive Officer of Mainz
Biomed. “The entire Mainz team is excited by the rapid growth
achieved to date and remains steadfast in our conviction to advance
an ambitious yet balanced strategy to maximize ColoAlert’s
potential in the marketplace, and to build our oncology-focused
diagnostic franchise via a unique commercial model and robust
technical approach to product development.”
Commercial Update: ColoAlert marketed across Europe via
unique business modelDuring the quarter, Mainz continued
its differentiated commercial plan of partnering with third-party
laboratories for test kit processing versus the traditional
methodology of operating a single facility. Under the standard
terms of all partnerships, Mainz is providing ColoAlert to the
respective labs, including co-branding with key accounts, whereby
each facility purchases Mainz’s customized polymerase chain
reaction (PCR) assay kits on an on-demand basis and provides to
their respective network of physicians and patients a comprehensive
solution for advanced CRC protection. During the first quarter
(February 2022), Mainz announced a partnership with Labor MVZ Dr.
Stein + Kollegen (“Laboratory Mönchengladbach”), one of the largest
diagnostics laboratories in the North Rhine-Westphalia region of
Germany. The Lab services over 2,500 physicians, processing over
five million samples in total annually and screening approximately
1,000 patients per week specifically for CRC. With the addition of
Laboratory Mönchengladbach, Mainz now has four core partnerships
including GANZIMMUN Diagnostics AG, one of Europe’s leading
laboratories for preventive and complementary medicine which
processes approximately 5,500 laboratory orders daily.
ColoAlert R&D Update: ColoFuture study evaluating
acquired mRNA biomarkersIn February 2022, Mainz initiated
a clinical study (ColoFuture) to evaluate a portfolio of five gene
expression biomarkers acquired from Socpra Sciences Santé Et
Humaines S.E.C. in January 2022. The results from a published study
in the peer review journal MDPI (March 11, 2021) demonstrated that
these specific biomarkers have a high degree of effectiveness in
detecting CRC lesions including advanced adenomas (“AA”), a type of
pre-cancerous polyp often attributed to this deadly disease. As
such, the ColoFuture study will determine if the biomarkers enhance
ColoAlert’s technical profile to extend its capability to include
the identification of advanced adenomas (AA) while increasing
ColoAlert’s rates of diagnostic sensitivity and specificity. If the
data results from ColoFuture are successful, ColoAlert will be
positioned as the most robust and accurate at-home diagnostic
screening test on the market, as it will not only detect cancerous
polyps with a high degree of accuracy but has the potential to
prevent CRC through early detection of precancerous adenomas.
To ensure optimal study execution, the Company announced during
the first quarter strategic partnerships with Sentinel Diagnostics
and Alcedis GmbH. Sentinel Diagnostics is a global leader in the
development and production of in vitro diagnostics (IVD), and
Alcedis GmbH is a full-service state-of-the-art contract research
organization (CRO) providing clinical trial management for
biotechnology and medical device companies across the globe. With
Sentinel, Mainz has been granted access to the SENTiFIT® 270
Analyzer, Sentinel’s leading automated Fecal Immunochemical Test
(FIT) processing system. An essential component of ColoAlert is the
utilization of a FIT which provides a complete review of blood in
the stool, a condition often associated with cancerous polyps and
colorectal carcinoma. It is the combination of ColoAlert and FIT
results that provide the diagnostic outcome. This partnership
enables Mainz to transition from deploying a manual FIT processing
methodology to a state-of-the-art automated system for potential
future use in the EU commercial setting, and in the Company’s
forthcoming U.S. clinical trial. Alcedis is providing Mainz with
the full range of services and responsibilities associated with
executing ColoFuture, including patient recruitment, overseeing
study protocol compliance, and the documentation and reporting of
patient results.
The ColoFuture study will enroll over 600 patients in the age
range of 40-85 at two participating centers in Norway and two in
Germany. The Company expects to complete enrollment during the
second half of 2022 and is targeting reporting study results in
early 2023. Additionally, data results from ColoFuture will impact
ColoAlert’s profile for FDA submission.
ColoAlert’s U.S. Regulatory Approval Update:
Pre-submission for pivotal trial design receives feedback from the
FDA and medical reimbursement process launched with CMSIn
March 2022, Mainz announced that it received supportive feedback
from the U.S. Food & Drug Administration on its pre-submission
package for ColoAlert. The Company will continue working with its
clinical team to finalize the study’s protocols and prepare for the
multi-center study which is on track to commence in late 2022. As
part of the Company’s activities to prepare for the initiation of
the pivotal trial, Mainz also announced the formal commencement of
its medical reimbursement process for ColoAlert by scheduling an
initial meeting with the Centers for Medicare and Medicaid Services
(CMS) which is set to take place in April 2022. CMS is a federal
agency in the U.S. Department of Health and Human Services (HHS)
that administers the Medicare program and works in partnership with
state governments to administer Medicaid, the Children's Health
Insurance Program (CHIP), and health insurance portability
standards.
Corporate Update: Successful follow-on offering, key
appointments to management team & Strategic Advisory
Board.In January 2022, the Company announced a $25.8
million public follow-on offering consisting of 1,725,000 of
ordinary shares priced at $15.00 per share. Boustead Securities,
LLC acted as the sole underwriter for the transaction. The Company
plans to file its Report on Form 20-F, including audited financial
statements for 2021, with the U.S. Securities and Exchange
Commission in April 2022.
Throughout the first quarter, the Company continued to bolster
its leadership team highlighted by the appointments of former
Abbott Diagnostics executive Steve Quinn as Vice President of
Business Development (January) along with the two high profile
additions to Mainz’s Strategic Advisory Board. In January, Dr.
Michele Pedrocchi joined the SAB followed by the February
appointment of Dr. Rainer Metzger. Dr. Pedrocchi is the former Head
of Roche Diagnostics Business Development and brings to the SAB
over 25 years of international experience at Roche spanning in
vitro diagnostics, digital health, and personalized medicine. Dr.
Metzger is a Former Danaher, Roche and Qiagen Executive with over
25 years of experience within the pharmaceutical and diagnostic
industries.
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
estimates that in 2021 there will be 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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