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 financial results for the
first half of the fiscal year ended June 30, 2022.
Key Corporate & Product Development
Highlights
- Accelerated international commercial activities for ColoAlert,
the Company’s highly efficacious and easy-to-use detection test for
colorectal cancer (CRC)
- Appointed Darin Leigh, former Abbott and Luminex executive, as
Chief Commercial Officer
- Established partnership with Dante Labs to market ColoAlert in
Italy and the United Arab Emirates
- Initiated and enrolled the first patient in an international
clinical study (ColoFuture) evaluating the integration of novel
mRNA biomarkers into ColoAlert – potentially upgrading its
technical profile to achieve “gold standard” status for CRC at-home
testing
- 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 set to commence in Q4 2022
- Achieved multiple preclinical milestones supporting the
continued development of PancAlert, a potential first-in-class
screening test for pancreatic cancer
- Executed a $25.8 million (gross) public follow-on offering
- Expanded Strategic Advisory Board of global leaders in
molecular diagnostic development and commercialization
“At the outset of 2022, we established ambitious commercial and
product development objectives for the year, mostly around our
flagship product ColoAlert. I’m pleased to report that we achieved
all of our corporate growth goals for the first half period,”
commented Guido Baechler, Chief Executive Officer of Mainz Biomed.
“The Company is financially well positioned to maintain momentum as
ColoAlert continues to gain impressive commercial traction across
Europe and select international territories, and as we ramp up to
launch its U.S. pivotal clinical trial by the end of the year.”
Commercial Update: ColoAlert continues to grow market
presence via a unique business model
Throughout the first half of 2022, Mainz 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 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 their
respective network of physicians and patients with a comprehensive
solution for advanced CRC detection.
The Company hired former Abbott and Luminex executive Darin
Leigh as its Chief Commercial Officer (April) to drive growth. Mr.
Leigh brings over 30 years of In Vitro Diagnostic (IVD) and life
science experience to Mainz and is currently responsible for
driving ColoAlert’s market expansion in Europe and international
territories.
The Company is pleased to report key commercial highlights
during the first half of 2022, including announcing high-profile
partnerships with leading laboratories such as Labor MVZ Dr. Stein
+ Kollegen, commonly referred to as “Laboratory Mönchengladbach”
(February), covering the North Rhine-Westphalia region (NRW) of
Germany, and Dante Labs (May) for Italy and the United Arab
Emirates (UAE). Laboratory Mönchengladbach is one of the largest
diagnostics laboratories in Germany, servicing over 2,500
physicians, processing over five million samples annually and
screening approximately 1,000 patients per week specifically for
CRC. Dante Labs is a global leader in genome sequencing with a
product development and commercial franchise focused on providing
preventive healthcare solutions to consumers and healthcare
professionals. Inherent to Dante Lab’s business model is managing
state-of-the-art genomic sequencing laboratories in multiple
international regions and operating a robust e-commerce platform.
With the addition of Laboratory Mönchengladbach and Dante Labs,
Mainz now has five 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 biomarkers
In June 2022, Mainz announced the first patient was enrolled in
ColoFuture, an international multi-center clinical study assessing
the potential to integrate a portfolio of novel gene expression
(mRNA) biomarkers into ColoAlert. The mRNA biomarkers were acquired
from the Université de Sherbrooke in January 2022 and are the
result of the institution’s pioneering work in the field, where
researchers tested multiple novel transcriptional biomarkers using
colorectal cancer and precancerous lesion samples. The results from
these studies demonstrated that the mRNA targets chosen by Mainz
provided a market-leading combination of sensitivity and
specificity of detection (Herring et al. 2021). The ColoFuture
study is evaluating the effectiveness of these biomarkers to
enhance ColoAlert’s technical profile to extend its capability to
identify advanced adenomas (AA), a type of pre-cancerous polyp
often attributed to CRC, while increasing ColoAlert’s rates of
diagnostic sensitivity and specificity.
The ColoFuture study is enrolling over 600 patients in the age
range of 40-85, and the Company is targeting reporting study
results in early 2023. If 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. Additionally,
data results from ColoFuture will potentially be incorporated into
ColoAlert’s pivotal U.S. clinical study.
ColoAlert’s U.S. Regulatory Approval Update:
Pre-submission for pivotal trial design receives feedback from the
FDA, and the medical reimbursement process launched with
CMS
In 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). 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.
PancAlert R&D Update: Novel
screening test for pancreatic cancer achieved multiple preclinical
milestones
In May, Mainz announced that PancAlert met multiple preclinical
milestones that support the continued development of this potential
first-in-class diagnostic for this deadly cancer indication.
Multiple predefined milestones for the PancAlert project were
accomplished, including achievement of specificity target,
collection of a set of characterized clinical samples, selection of
potential biomarker candidates, and the development of a prototype
biomarker test. The Company is continuing PancAlert’s R&D to
determine if a clinical trial is warranted.
PancAlert’s technical profile may include functioning as a
stool-based test, mirroring the Company’s flagship product
ColoAlert. Given the growing understanding of the role of the
microbiome in pancreatic cancer, Mainz will evaluate real-time
Polymerase Chain Reaction (“PCR”)-based multiplex detection of
molecular-genetic biomarkers and other testing methods in stool
samples and will also evaluate other collection methodologies
including saliva, urine and blood.
The PancAlert project commenced in 2020 with a grant from the
German Federal Ministry of Education and Research to develop a
non-invasive early detection test for pancreatic cancer, a
malignant neoplasm of the pancreas with one of the highest
mortality rates of all major cancers. Each year, about 466,000
lives are taken globally, and it’s the seventh leading cause of
cancer-related death worldwide.1 It has one of the lowest cancer
survival rates, with typically late detection and poor outcomes
with standard-of-care treatment(s). The 5-year overall survival
rate is approximately 11% in the U.S.2 and 9% globally.3 However,
if diagnosis occurs in the early stages of the disease, the
survival rate is significantly higher, hence the rationale behind
launching the PancAlert initiative.
Corporate Update: Successful follow-on offering, key
appointments to management team & Strategic Advisory Board of
global leaders in molecular diagnostic development and
commercialization
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.
Throughout the first half of 2022, 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) and Jane Edwards (June), as Vice
President of Clinical Affairs. Ms. Edwards, who brings over 20
years of senior experience developing clinical trial strategies in
diagnostics and medical devices, will lead all of the Company’s
clinical trials in the U.S. and Europe including ColoAlert’s
forthcoming U.S. pivotal study. An integral part of Mainz’s
corporate operational methodology is access to a Strategic Advisory
Board (SAB). To this end, Mainz appointed two high profile
additions to the SAB in the first quarter of 2022: In January, Dr.
Michele Pedrocchi joined, 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.
References
- Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I,
Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates
of Incidence and Mortality Worldwide for 36 Cancers in 185
Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi:
10.3322/caac.21660. Epub 2021 Feb 4. PMID: 33538338. The online
GLOBOCAN 2020 database is accessible at http://gco.iarc.fr/,
as part of IARC’s Global Cancer Observatory.
- National Cancer Institute, Surveillance, Epidemiology and End
Results Program (SEER). Cancer Stat Facts: Pancreatic Cancer. July
2021. https://seer.cancer.gov/statfacts/html/pancreas.html
- Rawla P, Sunkara T, Gaduputi V. Epidemiology of Pancreatic
Cancer: Global Trends, Etiology and Risk Factors. World J Oncol.
2019;10(1):10-27. doi:10.14740/wjon1166
Financial Results Overview
Mainz Biomed N.V. |
Condensed Consolidated Statements of Financial
Position |
June 30, 2022 and December 31, 2021 |
(unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
June 30, |
|
December 31, |
|
|
|
|
|
2022 |
|
2021 |
|
|
ASSETS |
|
|
|
|
|
|
|
Current
assets |
|
|
|
|
|
|
|
Cash and cash equivalents |
|
|
$ |
26,006,609 |
|
$ |
8,727,542 |
|
|
Trade and other
receivables, net |
|
|
332,918 |
|
111,842 |
|
|
Other assets |
|
|
458,784 |
|
769,825 |
|
|
TOTAL CURRENT
ASSETS |
|
|
26,798,311 |
|
9,609,209 |
|
|
|
|
|
|
|
|
|
|
Fixed and other
assets |
|
|
817,041 |
|
431,586 |
|
|
|
|
|
|
|
|
|
|
TOTAL
ASSETS |
|
|
$ |
27,615,352 |
|
$ |
10,040,795 |
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND
SHAREHOLDERS' EQUITY (DEFICIT) |
|
|
|
|
|
|
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Current
liabilities |
|
|
|
|
|
|
|
Accounts payable and
other accrued liabilities |
|
|
$ |
1,205,788 |
|
$ |
784,786 |
|
|
Current maturities of
long-term debt |
|
|
1,108,658 |
|
278,183 |
|
|
Other current
liabilities |
|
|
159,116 |
|
288,786 |
|
|
TOTAL CURRENT
LIABILITIES |
|
|
2,473,562 |
|
1,351,755 |
|
|
|
|
|
|
|
|
|
|
Long term debt |
|
|
894,832 |
|
1,940,119 |
|
|
Other liabilities |
|
|
475,148 |
|
387,766 |
|
|
TOTAL
LIABILITIES |
|
|
3,843,542 |
|
3,679,640 |
|
|
|
|
|
|
|
|
|
|
TOTAL SHAREHOLDERS' EQUITY (DEFICIT) |
|
23,771,810 |
|
6,361,155 |
|
|
|
|
|
|
|
|
|
|
TOTAL
LIABILITIES AND SHAREHOLDERS' EQUITY (DEFICIT) |
|
|
$ 27,615,352 |
|
$ 10,040,795 |
|
|
|
|
|
|
|
|
|
Mainz Biomed N.V. |
Condensed Consolidated Statements of Profit and
Loss and Comprehensive Loss |
For the Six Months Ended June 30, 2022 and
2021 |
(unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
Six months ended June 30, |
|
|
|
|
|
2022 |
|
2021 |
|
|
|
|
|
|
|
|
|
|
REVENUE |
|
|
|
|
|
|
|
ColoAlert revenue |
|
|
$ |
238,255 |
|
$ |
104,851 |
|
|
Other revenue |
|
|
1,550 |
|
312,460 |
|
|
TOTAL
REVENUE |
|
|
239,805 |
|
417,311 |
|
|
Cost of Revenue |
|
|
119,005 |
|
64,772 |
|
|
GROSS
PROFIT |
|
|
120,800 |
|
352,539 |
|
|
OPERATING
EXPENSES |
|
|
|
|
|
|
|
Research and
Development |
|
|
911,716 |
|
206,146 |
|
|
Sales and Marketing |
|
|
2,520,496 |
|
150,335 |
|
|
General and
Administration |
|
|
9,268,054 |
|
250,692 |
|
|
TOTAL OPERATING
EXPENSES |
|
|
12,700,266 |
|
607,173 |
|
|
OPERATING
LOSS |
|
|
(12,579,466) |
|
(254,634) |
|
|
Other Expenses |
|
|
22,981 |
|
7,087 |
|
|
NET
LOSS |
|
|
$ |
(12,602,447) |
|
$ |
(261,721) |
|
|
TOTAL
COMPREHENSIVE LOSS |
|
|
$ |
(12,519,804) |
|
$ |
(178,758) |
|
|
BASIC AND DILUTE
LOSS PER COMMON SHARE |
|
|
$ |
(0.91) |
|
$ |
(0.05) |
|
|
WEIGHTED AVERAGE
NUMBER OF ORDINARY SHARES OUTSTANDING |
|
|
13,821,914 |
|
5,607,243 |
|
|
|
|
|
|
|
|
|
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-IVDR marked (complying with EU safety,
health and environmental requirements). The product is commercially
available in a selection of countries in the European Union and in
the United Arab Emirates. 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 Pancreatic CancerEach year, about 466,000
lives are taken globally, and it’s the seventh leading cause of
cancer-related death worldwide.1 It has one of the lowest survival
rates of any cancer, with typically late detection and poor
outcomes with standard of care treatment(s). The 5-year overall
survival rate is approximately 11% in the U.S.2 and 9% globally.3
However, if diagnosis occurs in the early stages of the disease,
the survival rate is significantly higher, hence the rationale
behind launching the PancAlert initiative.
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 and in the United Arab Emirates
with the intention of beginning its pivotal FDA clinical study in
2022 for U.S. regulatory approval. Mainz Biomed’s product candidate
portfolio also 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.
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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