Mainz Biomed Reports 2024 Financial Results and Provides Corporate Update
Lab network revenue increased by 33% year over year, reflecting strong demand for ColoAlert$(R)$ in Europe
Operating loss decreased by 30% and net loss by 18%, driven by targeted cost reductions and a sharper strategic focus
Strategic partnerships with industry leaders mark key progress
Company highlights its early accomplishments for 2025
BERKELEY, Calif. and MAINZ, Germany, April 01, 2025 (GLOBE NEWSWIRE) -- Mainz Biomed N.V. $(MYNZ)$ ("Mainz Biomed" or the "Company"), a molecular genetics diagnostic company specializing in the early detection of cancer, announced today financial results for the year ended December 31, 2024, a summary on 2024 accomplishments, and an update on corporate developments for early 2025.
Key 2024 Accomplishments
-- Mainz Biomed and Thermo Fisher Scientific signed a collaboration
agreement for the development of the Company's next generation colorectal
cancer $(CRC)$ screening product for global markets. The agreement will
enable Mainz Biomed and Thermo Fisher to jointly develop and potentially
commercialize Mainz Biomed's next generation colorectal cancer screening
product. The collaboration will harness Thermo Fisher's powerful
technologies, instrumentation and information translation systems to
allow Mainz Biomed to develop the proprietary assays for its mRNA-based
next-generation CRC screening tests which are redefining standards in
early cancer detection.
-- Mainz Biomed entered into an agreement with Quest Diagnostics to provide
clinical trial laboratory services for Mainz Biomeds's ReconAAsense study,
a prospective clinical study that will include approximately 15,000
subjects from 150 sites across the United States to develop data
supporting FDA validation of the next generation test. In addition, Mainz
Biomed will provide Quest with the option to exercise semi-exclusive
rights to provide testing services based on the test kit for an
eighteen-month period, assuming its approval by the FDA.
-- Mainz Biomed executed an $8.0 Million follow-on offering for 1,367,521
units sold at an offering price of $5.85 per unit, priced at-the-market
under Nasdaq rules. Each unit included an ordinary share, a Series A
warrant and a Series B warrant. Each Series A warrant is immediately
exercisable at an exercise price of $5.85 per share and will expire five
years from the date of issuance. Each Series B warrant is immediately
exercisable at an exercise price of $5.85 per share and will expire on
the earlier of 30 days following receipt of results from the Company's
eAArly Detect 2 study and one year from the date of issuance.
-- In October 2024, the Company made a strategic decision to focus its
efforts on three key initiatives for the remainder of 2024 and into 2025
in order to maximize shareholder value. Those initiatives are:
-- The continued growth of its ColoAlert(R) business in Europe
through its distribution/lab partner network;
-- Development of its next generation colorectal cancer screening
product; and
-- Running a 2,000 patient study, with average risk patients in the
U.S., to read out by the end of 2025 (eAArly DETECT 2). With
eAArly DETECT 2, the Company addresses FDA feedback and prepares
for a new submission for breakthrough device designation with an
expanded data set, including a larger average-risk patient
population.
-- During 2024, Mainz Biomed's revenue from sales through its lab partner
network increased by 33% year over year; this increase was tempered by a
decrease in direct-to-consumer sales as the Company ceased its efforts in
that unprofitable channel.
-- In 2024, Mainz Biomed's loss from operations and net loss decreased by
30% and 18%, respectively. These decreases are the result of the
Company's efforts to reduce costs and focus on its three key initiatives
for 2025.
-- Mainz Biomed published key findings from its groundbreaking eAArly DETECT
study during a poster presentation at the renowned Digestive Disease Week
(DDW) 2024 in Washington D.C. The Company was awarded as a Poster of
Distinction by the Digestive Disease Week judges for the presentation of
industry leading results: 97% sensitivity for colorectal cancer and 82%
for advanced precancerous lesions. The eAArly DETECT results demonstrated
that within the advanced precancerous lesion patients, 100% of those
patients with high grade dysplasia were detected.
-- The Company presented pivotal data from its largest cohort to date during
a poster presentation at the American Society of Clinical Oncology (ASCO)
2024 Annual Meeting in Chicago, Illinois. This data combined results from
the ColoFuture and eAArly DETECT studies including additional patient
samples collected since the first reported study results. The new study
data confirmed previous ColoFuture and eAArly DETECT study performance
with sensitivity for CRC of 92% and 82% for advanced adenomas, including
96% detection of high-grade dysplasia.
-- Mainz Biomed expanded its collaboration with Liquid Biosciences to the
Company's next-generation detection test for pancreatic cancer. The
companies are leveraging Liquid Biosciences proprietary AI analysis
technology platform (EMERGE) to extend and optimize the selection of
novel biomarkers for PancAlert.
Early 2025 Updates
-- On January 23, 2025, the Company received formal notice from Nasdaq
confirming that it had regained compliance with the minimum stockholders'
equity requirement for continued listing on the Nasdaq Capital Market set
forth in Listing Rule 5550(b)(1). Mainz Biomed had previously received
confirmation that it had regained compliance with the minimum bid price
requirement set forth in Nasdaq Listing Rule 5550(a)(2). Mainz Biomed is
now in full compliance with all Nasdaq continued listing requirements.
-- The Company reported the first patient has been enrolled in eAArly DETECT
2, a feasibility study to evaluate the Company's next-generation
colorectal cancer (CRC) test. The test integrates its proprietary mRNA
biomarkers, an AI-developed algorithm, and a FIT test over a population
of approximately 2,000 average-risk patients to validate the
industry-leading results of previous feasibility studies and support the
transition of CRC screening to CRC prevention. This keeps the Company on
schedule to report top-line results by the end of 2025.
-- Signed a license and option agreement with Liquid Biosciences to access
novel mRNA biomarkers for early detection of pancreatic cancer via blood
test. Independent validation of the algorithm-biomarker combination
showed 95% sensitivity and 98% specificity.
"We are proud of the accomplishments our team achieved in 2024, which was a transitional year for Mainz Biomed," commented Guido Baechler, Chief Executive Officer of Mainz Biomed. "While navigating through a period of difficult market conditions, especially for small cap healthcare and technology stocks, we reached many significant milestones. As we look at our early results for 2025, we are encouraged by the progress of our eAArly DETECT 2 study and by our recently announced discovery and license of a suite of mRNA biomarkers, showing outstanding preliminary results for a blood-based pancreatic cancer detection test."
Condensed Consolidated Financial Statements (unaudited):
Mainz Biomed N.V.
Condensed Consolidated Statements of Financial Position
(unaudited)
(in U.S. Dollars)
December 31, December 31,
2024 2023
---------------------------------- ------------------------------
ASSETS
Current Assets
Cash $ 6,235,670 $ 7,070,925
Trade and other
receivables,
net 50,815 93,555
Inventories 372,870 613,638
Prepaid
expenses and
other current
assets 1,184,675 1,201,778
Total Current
Assets 7,844,030 8,979,896
Property and
equipment,
net 1,365,144 1,702,317
Intangible
assets 3,017,462 3,394,645
Right-of-use
assets 1,011,531 1,332,170
Total assets $ 13,238,167 $ 15,409,028
================================= =============================
LIABILITIES AND
SHAREHOLDERS'
EQUITY
Current
Liabilities
Accounts
payable and
accrued
liabilities $ 2,853,572 $ 3,484,317
Deferred
Revenue - 138,889
Current
maturities of
long-term
debt 2,125,254 4,936,428
Intellectual
property
acquisition
liability -
related party 690,575 388,839
Lease
liabilities 280,145 288,463
Total current
liabilities 5,949,546 9,236,936
Long term debt - 1,030,166
Lease
liabilities 865,982 1,165,723
Intellectual
property
acquisition
liability -
related party 376,096 726,977
Total
Liabilities 7,191,624 12,159,802
--------------------------------- -----------------------------
Shareholders'
equity
Share capital 922,125 235,818
Share premium 69,065,027 51,507,526
Reserve 27,594,947 21,286,215
Accumulated
deficit (90,978,684) (69,328,021)
Accumulated
other
comprehensive
income (556,872) (452,312)
-----------------------------
Total
shareholders'
equity 6,046,543 3,249,226
--------------------------------- -----------------------------
Total
liabilities
and
shareholders'
equity $ 13,238,167 $ 15,409,028
================================= =============================
Condensed Consolidated Financial Statements (unaudited):
Mainz Biomed N.V.
Condensed Consolidated Statements of Profit or Loss
and Comprehensive Loss (unaudited)
(in U.S. Dollars)
Years ended
December 31,
----------------------------------------------------
2024 2023
------------------------- -------------------------
Revenue $ 893,991 $ 895,479
Cost of revenue 319,108 385,820
Gross profit 574,883 509,659
------------------------ ------------------------
Gross margin 64% 57%
Operating
expenses:
Sales and
marketing 6,581,333 6,158,477
Research and
development 5,839,033 9,590,393
General and
administrative 6,572,765 11,405,471
Restructuring
expense 277,160 -
Total operating
expenses 19,270,291 27,154,341
------------------------ ------------------------
Loss from
operations (18,695,408) (26,644,682)
Other income
(expense), net (2,955,255) 348,955
------------------------ ------------------------
Income (loss)
before income
tax (21,650,663) (26,295,727)
Income taxes
provision - -
------------------------
Net loss $ (21,650,663) $ (26,295,727)
======================== ========================
Foreign currency
translation gain
(loss) (104,560) (504,494)
Comprehensive loss $ (21,755,223) $ (26,800,221)
======================== ========================
Basic and dilutive
loss per ordinary
share $ (22.36) $ (64.76)
======================== ========================
Weighted average
number of
ordinary shares
outstanding 968,234 406,058
======================== ========================
Please visit Mainz Biomed's official website for investors at mainzbiomed.com/investors/ for more information
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About Mainz Biomed NV
Mainz Biomed develops market-ready molecular genetic diagnostic solutions for life-threatening conditions. The Company's flagship product is ColoAlert(R) , an accurate, non-invasive and easy-to-use, early-detection diagnostic test for colorectal cancer. ColoAlert(R) is marketed across Europe. The Company is currently running a development study to finalize with the next gen CRC screening test as preparation for the pivotal FDA clinical study for US 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. To learn more, visit mainzbiomed.com or follow us on LinkedIn, Twitter and Facebook.
For media inquiries
MC Services AG
Anne Hennecke / Maximilian Schur
+49 211 529252 17
mainzbiomed@mc-services.eu
For investor inquiries, 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; and (iii) 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 March 31, 2025. 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.
(END) Dow Jones Newswires
April 01, 2025 08:01 ET (12:01 GMT)
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