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 a year end summary of its
corporate and product development progress.
Key Commercial, Product Development and Operational
Highlights Included:
- Announced groundbreaking results
from ColoFuture (Europe) and eAArly DETECT (U.S.) clinical studies
evaluating the potential to integrate portfolio of novel gene
expression (mRNA) biomarkers into a next-generation version of
ColoAlert®.
- ColoFuture reported sensitivity for
colorectal cancer (CRC) of 94% with specificity of 97% and advanced
adenoma (AA) sensitivity of 80%.
- eAArly DETECT reported sensitivity
for CRC of 97% with a specificity of 97% and a sensitivity for AA
of 82%.
- Expanded international
commercialization of ColoAlert®, a highly efficacious and
easy-to-use DNA-based detection test for CRC being sold via
Company’s unique business model of marketing products via
partnerships with third-party laboratories versus the traditional
methodology of operating a single facility.
- Established commercial operations in
major markets including Spain, Poland, Romania, Portugal, Israel,
and the UK.
- Launched corporate health program
with Germany serving as initial market via integration into
Country’s BGM system (“betriebliches
Gesundheitsmanagement”).
- Ramped-up preparations for pivotal FDA PMA clinical trial
(ReconAAsense) which remains on track to commence patient
enrollment in mid-2024. Presents an opportunity to achieve
gold-standard status for at-home CRC screening.
“This past year was an exceptional period for the Company as we
executed our international commercial strategy for flagship product
ColoAlert® while advancing product development programs,” commented
Guido Baechler, Chief Executive Officer of Mainz Biomed. “The
latter half of 2023 was especially exciting given the
groundbreaking results from the ColoFuture and eAArly DETECT
studies which reported extraordinary statistical significance for
CRC lesion detection and advanced adenomas, a type of pre-cancerous
polyp often attributed to this deadly disease. This outstanding
outcome enables optimal trial design for the ReconAAsense pivotal
FDA PMA study that if successful, will now represent disruptive
innovation in self-administered CRC screening, providing the
opportunity to bring to market the most advanced diagnostic tool on
the market. As such, we head into 2024 with a great deal of
momentum as we make final preparations for ReconAAsense, with
patient enrollment targeted to commence mid-year. On the commercial
front, we’ll continue to expand our international footprint while
strengthening our presence in established markets.”
2023 Commercial Summary: Expanded international
partnership network and increased presence in established
markets.
Throughout 2023, Mainz Biomed executed 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 Biomed is providing ColoAlert® to the respective labs,
including co-branding with key accounts, whereby each facility
purchases Mainz Biomed’s customized polymerase chain reaction (PCR)
assay kits on an on-demand basis and provides their respective
network of physicians and patients with a comprehensive solution
for advanced CRC detection. During the year, Mainz Biomed expanded
its commercial operations in major international territories by
extending its network of laboratory and distribution partners while
continuing to gain traction in established markets.
During the year, Mainz Biomed launched commercial operations in
Spain, Portugal, Romania, Poland, the United Kingdom, and Israel.
For Spain and Portugal, the Company established a partnership with
The Instituto de Microecologia, widely known for its pioneering
work in intestinal health. The laboratory offers a wide range of
diagnostic and analytical services and is continuously advancing
its scientific and technical capabilities through ongoing internal
research alongside external collaborations. The Institute deploys
the most innovative diagnostic techniques by continuously auditing
procedures to ensure delivery of the highest standard of quality
and reliability of diagnostic results. According to the World
Cancer Research Fund International, CRC is the third most common
cancer worldwide and Portugal ranks seventh in total global CRC
rates with 10,501 cases reported in 2020. On its website, the
Institute lists CRC as the second leading cause of death from
cancer in Spain and the most frequent malignant tumor,
with over 41,000 new cases each year affecting 1 in 20
men and 1 in 30 women before the age of 74.
For the UK, Mainz Biomed is collaborating with Marylebone
Laboratory, which recently expanded its presence in London, under
the Marylebone Diagnostic Centre brand where it provides a
comprehensive range of screening and diagnostic testing services.
Across the UK, CRC remains a critical health concern, with
approximately 43,000 diagnoses and 16,800 deaths occurring each
year in the UK alone. This equates to an average of 46 lives lost
every day. With a population of 67 million people, the UK, presents
a substantial market for CRC screening. Specifically, within the
age groups of 40 to 49 years and 50 to 75 years, there are
approximately 8.4 million and 20 million individuals respectively.
Additionally, there are 6.2 million individuals aged over 75. With
a recommended frequency of CRC screening once every two years for
patients aged 50 to 74, ColoAlert® represents a pivotal tool in the
fight against this devastating disease. Considering these figures,
the addressable UK market for ColoAlert® amounts to a staggering
34.6 million potential users.
In Poland, Mainz Biomed partnered with testDNA Sp. z o. o. Sp. K
(“testDNA”), one of the country’s leading DNA-based testing
services. Its laboratory, headquartered in Katowice, Poland, boasts
an expansive network of over 300 collection points throughout the
country. Poland is a particularly important market as the need for
alternative CRC screening options is underscored by data from the
World Cancer Research Fund International which ranked Poland 7th
(seventh) in the world for the highest mortality rate. With over 21
million people aged over 40, the market opportunity for ColoAlert®
is significant, especially as there has been a low level of
national participation in CRC screening which traditionally has
been colonoscopies.
In Romania, Mainz Biomed secured a partnership with Bioclinica a
leading supplier of healthcare products in Romania, with over 25
years of experience in medical diagnostics. Through its 15
associated laboratories and 146 collection points, Bioclinica
provides state-of-the-art diagnostics to the Romanian population.
According to United Nations, Department of Economic and Social
Affairs population statistics, ColoAlert® screening has the
potential to benefit over 6 million individuals aged between 50 and
74 years in Romania where the CRC incidence rates are among the
highest in Europe.
Mainz Biomed entered the Israeli market via a partnership with
Fugene Genetics (FG). Founded in 2008, FG is a renowned genetic
testing service provider offering a wide range of advanced genetic
testing services to private clients, health organizations,
hospitals, and genetic institutes throughout the country. Israel
has one of the highest screening compliance rates in the world with
over one million people being screened each year. It is expected
that over 3.5 million adults could benefit from the availability of
ColoAlert® in Israel.
A major commercial objective for 2023 was to fortify the
Company’s presence in Germany, its flagship international market.
To this end, Mainz Biomed expanded its footprint with additional
laboratory partnership, increasing awareness of ColoAlert® in the
Country’s private health insurance segment, and by launching a
corporate health program via integration into the Country’s BGM
system (“betriebliches Gesundheitsmanagement”), an established
health initiative providing services to employees at 48 of the 50
largest companies in the country.
Key German partnership highlights included the establishing a
partnership with Dr Staber & Kollegen GmbH (Labor Staber),
which for more than 35 years, has been providing physicians and
hospitals with medical laboratory services at nine locations across
Germany.
During the year, integrating ColoAlert® into Germany’s private
health insurance reimbursement segment was an important initiative
and a significant highlight of this effort was partnering with
Ärztliches Labor Dr. Buhlmann, a respected player in PCR-based
analysis. Approximately 10.5% of Germany’s population, or roughly
8.7 million individuals, are covered by private health insurance
(PHI), as estimated by the Association of Substitute Health
Insurance Funds (vdek) in 2022. A substantial portion of these PHI
beneficiaries fall within the critical 50-74 age range, the target
demographic for CRC screening in Germany so clearly, this is an
important addressable market.
Mainz Biomed’s launch of a corporate health program in Germany
was the final piece to the German specific commercial strategy for
ColoAlert®. The Company’s integration into the Country’s BGM
(“betriebliches Gesundheitsmanagement”) corporate health network
provided access to a €1 billion annual market. The BGM provides
healthcare services to employees ranging from gym memberships to
diabetes management to counseling, all to better their health.
Mainz Biomed’s integration into these BGM programs included the
launch of an online portal through which employees can register to
be sent the ColoAlert test. Once the sample is received and
processed, confidential test results are sent back to the employee
through the portal, along with an explanation of the results. If an
employee has approved for their physician to also be notified, then
the doctor can follow up with the patient accordingly. Mainz Biomed
provides education for both the employee and physician regarding
the ColoAlert® results and CRC, as well as recommendations for next
steps.
2023 Product Development Summary: Achieved major
milestone by reporting groundbreaking ColoFuture and eAArly DETECT
study results which positioned U.S. pivotal clinical trial
(ReconAAsense) to evaluate a gold standard self-administered CRC
screening test. ReconAAsense on track to commence patient
enrollment in mid-2024.
From a product development standpoint, 2023 proved to be one of
the most exciting periods in the Company’s history as Mainz Biomed
reported groundbreaking results from its ColoFuture and eAArly
DETECT studies. These clinical trials assessed the potential to
integrate the Company’s portfolio of novel gene expression (mRNA)
biomarkers into its pivotal FDA PMA clinical trial (ReconAAsense)
which is evaluating a next-generation CRC at-home screening test.
The ability to integrate these biomarkers into ReconAAsense
represents a potentially game-changing innovation in CRC screening
as they previously demonstrated the ability to detect CRC lesions,
including advanced adenomas (AA), a type of pre-cancerous polyp
often attributed to this deadly disease. The ColoFuture study, a
multi-center international clinical trial, reported outstanding
topline results including demonstrated sensitivity for CRC of 94%
with specificity of 97% and AA sensitivity of 80%. Its U.S.
counterpart (eAArly DETECT) reported even more impressive top-line
data demonstrating sensitivity for CRC of 97% with specificity of
97% and AA sensitivity of 82%. Given this extraordinary outcome,
the Company is in the process of selecting the biomarkers for
inclusion into ReconAAsense, and is planning to initiate enrollment
in mid-2024.
The ReconAAsense clinical trial (ClinicalTrials.gov Identifier:
NCT05636085) is U.S. a pivotal clinical trial assessing Mainz
Biomed’s next-generation CRC test and will form the basis of the
data package for review by the U.S. Food and Drug Administration
(FDA) to achieve marketing authorization. It will include
approximately 15,000 subjects from 150 sites across the U.S. The
study’s primary objectives include calculating sensitivity,
specificity, positive predictive value (PPV) and negative
predictive value (NPV) in average-risk subjects for CRC and AA.
Given the integration of Mainz Biomed’s portfolio of novel gene
expression (mRNA) biomarkers into ReconAAsense, if the trial
produces positive results, this next iteration of Mainz Biomed’s
CRC test will be positioned as one of the most robust and accurate
at-home diagnostic screening solutions 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.
In conjunction with ColoFuture and eAArly DETECT the Company
entered into a strategic partnership with Liquid Biosciences, a
bio-analytics company leveraging its proprietary AI analysis
technology platform (EMERGE) to serve the biopharma and diagnostics
industries along with academic institutions. Since launching the
EMERGE bio-analytics platform, Liquid Biosciences is widely
considered to be the premier analytical partner to the life
sciences industry. Its technology has been deployed in over 170
projects for Big Pharma and emerging therapeutic and diagnostic
companies covering biomarker discovery, clinical trial screening
and post-FDA approval services such as patient treatment selection
and optimal dosing regiments. Key attributes of EMERGE that make it
superior to mainstream AI and machine learning analytical solutions
include its computational speed, ability to handle millions of
variables and operate agnostically, without any assumptions or
constraints. It was designed as a scalable, unbiased methodology to
produce transparent algorithms from complex data, without any prior
assumptions. This enables the identification of variables with
relatively low expression, but which may be functionally important
because of the non-linear interactions pervasive in complex
biologic systems.
Mainz Biomed also partnered with Microba Life Sciences, a
precision microbiome company leveraging a world-leading technology
platform for measuring the human gut microbiome to discover and
develop novel therapeutics for major diseases, for the development
of PancAlert, the Company’s early-stage screening test for
pancreatic cancer. As part of the agreement, Microba and Mainz
Biomed are conducting a pilot research project utilizing Microba’s
proprietary metagenomic sequencing technology and bioinformatic
tools to potentially discover novel microbiome biomarkers for
pancreatic cancer detection.
2023 Operational Summary: Bolstered leadership team and
strengthened financial position
During the year, Mainz Biomed continued to enhance its team with
an emphasis on commercial additions given ColoAlert®’s rapid
expansion in international markets. A key hire was Tarrin
Khairi-Taraki as Vice President of Commercial Operations, EMEA. Mr.
Khairi-Taraki’s prior experience includes serving as Regional
Manager for DACH and BENELUX at Natera, one of the four global
leading companies in the prenatal screening field and renowned for
its non-invasive, cell-free DNA testing technology. During his
tenure at Natera, Mr. Khairi-Taraki played an integral role in
driving significant growth through forming crucial collaborations
with laboratories, clinics, and practices as well as through
enhancing the effectiveness of lab partners’ sales teams. He brings
to Mainz Biomed expertise in market analysis and business
development strategies which at Natera, resulted in a strong
presence for the Company’s innovative Panorama Test across the DACH
region and in the highly successful introduction of the test in
Austria and the Netherlands.
On the financial front, Mainz Biomed executed two financial
transactions. The Company entered into an agreement with investment
management firm Yorkville Advisors Global LP which provides the
option to access up to $50 million via a Pre-Paid Advance
Arrangement and included two $5.5 million promissory notes. In
addition, during the latter part of the year, Mainz Biomed executed
a registered direct offering with several institutional investors
to purchase $5.0 million of its ordinary shares (or pre-funded
warrants to purchase ordinary shares in lieu thereof) and warrants
to purchase ordinary shares.
Please visit Mainz Biomed’s official website for investors at
mainzbiomed.com/investors/ for more information.
Please follow us to stay up to date:LinkedInX (Previously
Twitter)Facebook
About ColoAlert®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 across the country.
About Colorectal CancerColorectal 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 early-stage
pancreatic cancer screening test. To learn more, visit
mainzbiomed.com.
For media inquiries - In Europe:MC Services
AGAnne Hennecke/Caroline Bergmann+49 211 529252
20mainzbiomed@mc-services.eu
In the U.S.:Josh Stanbury+1 416 628 7441josh@sjspr.co
For investor inquiries, please
contact info@mainzbiomed.com
Forward-Looking StatementsCertain 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.
Mainz BioMed NV (NASDAQ:MYNZ)
Historical Stock Chart
From Nov 2024 to Dec 2024
Mainz BioMed NV (NASDAQ:MYNZ)
Historical Stock Chart
From Dec 2023 to Dec 2024