Total addressable market in Poland is estimated at 21 million patients

BERKELEY, Calif. and MAINZ, Germany, May 31, 2023 (GLOBE NEWSWIRE) -- Mainz Biomed NV (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”), a molecular genetics diagnostic company specializing in the early detection of cancer, announced today the establishment of a commercial partnership for ColoAlert ^® with TESTDNA Sp. z o.o. Sp. k. Katowice, Poland, a leading independent laboratory in Poland. ColoAlert is Mainz Biomed’s flagship product, a highly efficacious and easy to use, at-home detection test for colorectal cancer (CRC) currently being commercialized across Europe and in select international markets via a differentiated business model of partnering with third-party laboratories for test kit processing versus the traditional methodology of operating a single facility.

“Entering the Polish market is an important milestone for the Company and we are thrilled by the opportunity to partner with TESTDNA to establish ColoAlert’s commercial footprint in this territory,” commented Darin Leigh, Chief Commercial Officer of Mainz Biomed. “TESTDNA is an exciting addition to our growing network of international laboratory partners who are committed to providing cutting-edge diagnostic screening tools to improve patient survival and disease prevention from deadly indications such as CRC, the second most lethal cancer in Europe.”

According to Digestive Cancers Europe, Poland shows a particularly high need for reliable non-invasive screening methods, with only about one in five patients willing to use colonoscopy for screening. The incidence of 19,000 new cases annually with approximately 12,000 colorectal cancer-related deaths confirms the need for at-home screening tests with good early stage detection. The addressable market in Poland is estimated at 21 million patients.

Mainz Biomed is providing ColoAlert to TESTDNA under the standard terms of the Company’s partnership agreements. In the coming weeks, Mainz Biomed will work with TESTDNA to prepare and launch co-marketing activities to ensure successful commercialization in the Polish market.

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 ( Gies 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 Cancer
Colorectal 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 NV
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 or follow us on LinkedIn , Twitter and Facebook .

For media inquiries, please contact [email protected]
In Europe:

MC Services AG
Anne Hennecke/Caroline Bergmann
+49 211 529252 20
[email protected]

In the US:

Spectrum Science
Melissa Laverty/Valerie Enes
+1 540 272 6465
[email protected]

For investor inquiries, please contact [email protected]

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 annual report on Form 20-F filed on May 5, 2022. The Company’s SEC filings are available publicly on the SEC’s website at 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.

Employees found the online patient portal, through which they ordered the ColoAlert ^® test, easy-to-use and convenient

BERKELEY, Calif. and MAINZ, Germany, May 24, 2023 (GLOBE NEWSWIRE) -- Mainz Biomed NV (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”), a molecular genetics diagnostic company specializing in the early detection of cancer, announced today initial results from its colorectal cancer (CRC) screening campaign through its BGM (“betriebliches Gesundheitsmanagement”) partnership with Zöeller-Kipper GmbH, part of the Zöeller group with more than 2,500 employees. In April 2023, Zöeller-Kipper selected ColoAlert ^® , Mainz Biomed’s highly efficacious and easy-to-use screening test for CRC, for its corporate health program.

“We are incredibly pleased with these early results, as outcomes like these indicate what the future holds when patients have increased access to easy, convenient and affordable screening,” said Guido Baechler, Chief Executive Officer of Mainz Biomed. “As we expand the reach of ColoAlert, I am thankful for the dedication of our team members and partners, like Zöeller-Kipper, for spreading the importance of early detection screening as CRC is the second most lethal cancer nationally, with almost 73,000 new cases diagnosed each year in Germany.”

Using Mainz Biomed’s online portal, Zöeller-Kipper employees registered to be mailed the ColoAlert test. Once the sample was received and processed, confidential test results were sent back to the employee through the portal, along with an explanation of the results. If an employee had approved for a physician to be notified of test results, then the doctor could directly follow-up with the patient. As part of its commitment to the BGM program, Mainz Biomed provided education to employees and physicians on CRC and recommendations for next steps.

“Mainz Biomed made it easy for us to quickly implement ColoAlert as one of our BGM options,” said Irina Riffel, Head of HR of Zöeller-Kipper. “Our employees are able to readily access the patient portal, request a kit and securely receive their results within five days. Their feedback about the process is positive and we are pleased to offer them this test, as early CRC detection and diagnosis can lead to better treatment options and improved outcomes. Ensuring the health and well-being of our employees is paramount.”

“We would like to thank Zöeller-Kipper for this successful collaboration and their dedication to give their employees access to state-of-the-art CRC screening with ColoAlert,” added Mr. Baechler. “We look forward to participating in more programs like this with other companies throughout Germany and Europe.”

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 ( Gies 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 Cancer
Colorectal 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 NV
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 or follow us on LinkedIn , Twitter and Facebook .

For media inquiries, please contact [email protected]

In Europe:
MC Services AG
Anne Hennecke/Caroline Bergmann
+49 211 529252 20
[email protected]

In the US:
Spectrum Science
Melissa Laverty/Valerie Enes
+1 540 272 6465
[email protected]

For investor inquiries, please contact [email protected]

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 annual report on Form 20-F filed on May 5, 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.

ColoAlert ^® Revenue Increases 152% Year Over Year

BERKELEY, Calif. and MAINZ, Germany, May 16, 2023 (GLOBE NEWSWIRE) -- 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 first quarter results which ended March 31, 2023 and provided a corporate update.

Key Highlights During Q1 2023

• ColoAlert ^® revenues were USD 250,077, representing an increase of 152% compared to Q1 2022
• Expanded the international commercialization for ColoAlert, Mainz Biomed’s highly efficacious and easy-to-use DNA-based detection test for colorectal cancer (CRC) being sold via the Company’s unique business model of marketing products via partnerships with third-party laboratories versus the traditional methodology of operating a single facility
• Grew network of laboratory partnerships across Europe with additions in Germany, Spain and England
• Launched corporate health program in Germany accessing a EURO 1 billion annual market - Integration into Country’s “BGM” system providing employee health services
• U.S. Pivotal Clinical Trial (ReconAAsense) remains on track to commence patient enrollment in 2H 2023 – Opportunity to achieve gold standard status for self-administered CRC screening
• Exercised exclusive option with Uni Targeting Research AS to acquire all of the previously licensed scientific IP for ColoAlert
• Acquired entire IP portfolio for family of novel gene expression (mRNA) biomarkers from Sciences Sante et Humaines S.E.C. (“SOCPRA”) that demonstrated ability to detect CRC lesions, including advanced adenomas (“AA”), a type of pre-cancerous polyp often attributed to CRC
• Continued executing European and U.S. clinical studies (ColoFuture/eAArly DETECT) evaluating the SOCPRA biomarker portfolio for potential inclusion in ReconAAsense - eAArly DETECT on track to report results in mid-2023 & ColoFuture’s readout is expected in H2 2023.
• Maintained development pace for pipeline asset PancAlert, a potential first-in-class screening test for pancreatic cancer
  

“The first quarter of 2023 proved to be a remarkable period of progress as we continue to build-out ColoAlert’s commercial franchise across Europe while executing on our programs in development, highlighted by the commencement of patient enrollment in the U.S. pivotal study for our CRC test by end of year,” commented Guido Baechler, Chief Executive Officer of Mainz Biomed. “As we prepare for this milestone, we eagerly await the results from the eAArly DETECT clinical trial which if successful, will integrate biomarkers from the SOCPRA portfolio into ReconAAsense, representing the opportunity to bring to market a disruptive, groundbreaking CRC screening solution for early stage disease detection and prevention.”

Commercial Update: Broadened ColoAlert’s commercial reach in key European markets
During the quarter, Mainz Biomed continued ColoAlert’s European commercial roll-out by establishing partnerships with Marylebone Laboratory (Marylebone Lab LTD) and Instituto de Microecologia, two leading independent laboratories covering England, Spain and Portugal. The addressable market in Spain is estimated at 26 million patients and at 9 million patients in the greater London region. In Germany, Mainz Biomed expanded ColoAlert’s availability in the country through a partnership with Dr Staber & Kollegen GmbH (Labor Staber), and the launch of a corporate health program focused on companies across the country, representing a EURO 1 billion annual market. For over 35 years, Labor Staber has been providing physicians and hospitals with medical laboratory services at nine locations across Germany. Mainz Biomed’s corporate health program for ColoAlert was launched through integration into BGM (“betriebliches Gesundheitsmanagement”), a well established corporate health initiative providing services to employees at forty-eight of the fifty largest companies in Germany. Through corporate health management programs such as BGM, best-in-class companies offer employees healthcare services ranging from gym memberships to diabetes management to counseling, all to better their health. Mainz Biomed’s integration into BGM includes the launch of an online portal through which employees can register to be sent the ColoAlert test.

Product Development Update: ReconAAsense U.S. pivotal clinical trial, ColoFuture/eAArly DETECT clinical studies & pancreatic test advancements
Throughout the first quarter, Mainz Biomed continued to prepare for commencing patient enrollment in the ReconAAsense study (ClinicalTrials.gov Identifier: NCT05636085) in H2 2023. This U.S. pivotal clinical trial assessing Mainz Biomed’s CRC test 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., and 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. Additionally, Mainz Biomed continued executing its ColoFuture (Europe) and eAArly DETECT (U.S.) studies evaluating the Company’s proprietary portfolio of novel gene expression (mRNA) biomarkers for possible inclusion in the ReconAAsense trial because they have previously demonstrated ability to detect CRC lesions, including AA, a type of pre-cancerous polyp often attributed to this deadly disease.

The eAArly DETECT clinical trial, which commenced enrollment in December of 2022, remains on track to report results in mid-2023. The multi-center feasibility study is enrolling 250 subjects across 25 sites in the U.S.. The international multi-center ColoFuture study continued enrolling patients in Europe (recruiting over 600 patients in the age range of 40-85) with results expected in H2 2023. If any of the biomarkers are integrated into the ReconAAsense trial and the study produces positive results, this next iteration of Mainz Biomed’s CRC test will be positioned as the most robust and accurate at-home diagnostic screening solution 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 this end, a promising research milestone was achieved during the quarter when Mainz Biomed announced positive results from an independent feasibility study conducted in collaboration with members of the Early Detection Research Network (EDRN) to evaluate the same portfolio of gene expression biomarkers. Key findings included Mainz Biomed’s proprietary nucleic acid extraction and PCR process proved to be highly effective, and two of the mRNA biomarkers were found to be particularly valuable in detecting disease signals in advanced adenoma samples.

During the quarter, Mainz Biomed continued to conduct pre-clinical work on PancAlert, the Company’s novel and potential first-in-class early detection test for pancreatic cancer, a malignant neoplasm of the pancreas with one of the highest mortality rates of all major cancers. In fact, a recent highlight (May 10 ^th , 2023) was the establishment of a research partnership with Microba Life Sciences (ASX: MAP), a precision microbiome company that is built around a unique metagenomic platform technology with the ability to produce comprehensive and accurate species profiles of human gastrointestinal samples. The collaboration will focus on leveraging this sequencing technology and bioinformatic tool to potentially discover novel microbiome biomarkers for pancreatic cancer detection for integration into PancAlert’s technical configuration.

Corporate Update: Acquired entire IP portfolio for colorectal cancer program
A major corporate growth milestone achieved during the first quarter was executing the Company’s option from Uni Targeting Research AS to acquire all of the previously licensed scientific intellectual property (“IP”) for ColoAlert. In addition and in synchronicity with this transaction, Mainz Biomed exercised its exclusive option with SOCPRA Sciences Sante et Humaines S.E.C. to outright purchase all of the IP, including a pending patent associated with the portfolio of novel gene expression (mRNA) biomarkers that are being evaluated in the ColoFuture/eAArly DETECT studies, and which may be integrated into the ReconAAsense pivotal trial. Securing complete IP ownership of these assets is a significant value generating milestone for Mainz Biomed as it streamlines administration, reduces per-test expenses, and provides the opportunity to ramp-up corporate development activities.

CONDENSED CONSOLIDATED FINANCIAL INFORMATION
During the three months ended March 31, 2023 the Company saw its revenue from ColoAlert grow 152% compared to the same period of 2022, with gross margins expanding from 46% to 56%. During the first three months of 2023, the Company’s operating loss grew from USD 5.7 million to USD 6.5 million, when compared to the first three months of 2022. This increased loss was attributable to growth of sales and marketing and research and development (R&D) costs, mitigated by a decrease in general and administrative costs. Sales & marketing expenses increased as planned due to the expansion of the Company’s commercial activities in Europe. The increased research and development expenses are attributable to the continued development of Mainz Biomed’s next generation colorectal cancer screening test and, during the first quarter of 2023, and continuing into the second quarter, the Company incurred increased R&D costs related to the peak enrollment in its eAArly Detect study in the U.S. With peak enrollment completed, thereby reducing its monthly operating expenses for the second half of the year, and with USD 10.9 million cash on hand at quarter end, the Company believes that it has cash runway past the end of 2023.

The Company has filed a current report on Form 6-K on May 16, 2023, with the U.S. Securities and Exchange Commission, which includes both consolidated financial statements and management’s discussion and analysis of its financial results for the first quarter of 2023. Summary financial tables are included below.

About Mainz Biomed NV
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 or follow us on LinkedIn , Twitter and Facebook .

For media inquiries, please contact [email protected]

In Europe:
MC Services AG
Anne Hennecke/Caroline Bergmann
+49 211 529252 20
[email protected]

In the US:
Spectrum Science
Melissa Laverty/Valerie Enes
+1 540 272 6465
[email protected]

For investor inquiries, please contact [email protected]

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 annual report on Form 20-F filed on May 5, 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.

• Combination of DNA biomarkers with microbiome biomarkers has potential to enhance technical profile of novel pancreatic cancer screening test

• Joint research project to discover disease specific microbiome biomarkers

BERKELEY, Calif. and MAINZ, Germany, May 10, 2023 (GLOBE NEWSWIRE) -- 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 research collaboration with Microba Life Sciences (ASX: MAP) (“Microba”), 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. As part of the agreement, Microba and Mainz Biomed will conduct a pilot research project utilizing Microba’s proprietary metagenomic sequencing technology and bioinformatic tools to potentially discover novel microbiome biomarkers for pancreatic cancer detection.

Pancreatic cancer is 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 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.

“We are excited by the opportunity to collaborate with Microba as PancAlert is being developed for early-stage disease detection with the goal of being a first-in-class screening test for this deadly form of cancer,” commented Guido Baechler, Chief Executive Officer of Mainz Biomed. “Given the growing understanding of the microbiome’s role in pancreatic cancer, we believe it’s of paramount importance to explore integrating diagnostic microbiome biomarkers into the test as it advances to the clinical stage of development and as such, are delighted to align with a global leader in sourcing and analyzing microbiome generated species and datasets.”

The project is expected to run through late 2023 and will deploy Microba’s Community Profiler (MCP), Microba’s unique metagenomic platform technology. MCP has been established as a best-in-class research tool with the ability to produce comprehensive and accurate species profiles of human gastrointestinal samples. Mainz Biomed is currently commercializing its flagship product ColoAlert ^® , a highly efficacious and easy-to-use detection test for colorectal cancer (CRC) in select international territories and in December of 2022, initiated a U.S. Pivotal Clinical Study (ReconAAsense) for a CRC screening test that may integrate the Company’s portfolio of novel gene expression (mRNA) biomarkers. These biomarkers have demonstrated potential to identify advanced adenomas, a type of curable pre-cancerous polyp often attributed to CRC that are being evaluated in European and U.S. studies (ColoFuture/eAArly DETECT). Results from eAArly DETECT are expected in mid-2023 and Mainz anticipates enrollment in ReconAAsense to commence in the second half of 2023.

References

1. 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.
2. 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
3. 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
   
   

About Mainz Biomed NV
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 marketed across Europe and the United Arab Emirates. The Company is currently 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 based on real-time Polymerase Chain Reaction-based (PCR) multiplex detection of molecular-genetic biomarkers in stool samples. To learn more, visit mainzbiomed.com or follow us on LinkedIn , Twitter and Facebook .

For media inquiries, please contact [email protected]
In Europe:
MC Services AG
Anne Hennecke/Caroline Bergmann
+49 211 529252 20
[email protected]

In the US:
Spectrum Science
Melissa Laverty/Valerie Enes
+1 540 272 6465
[email protected]

For investor inquiries, please contact [email protected]

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 20-F filed on May 5, 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.

Eurofins GeLaMed to provide test kit processing of ColoAlert ^® through Germany

BERKELEY, Calif. and MAINZ, Germany, May 03, 2023 (GLOBE NEWSWIRE) -- Mainz Biomed NV (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”), a molecular genetics diagnostic company specializing in the early detection of cancer, announced today that it has added Eurofins GeLaMed to its network of lab partners offering PCR test kit processing of ColoAlert ^® , its flagship product that is a highly efficacious and easy to use at-home screening test for colorectal cancer (CRC). Eurofins GeLaMed has four locations throughout Germany and is part of Eurofins Scientific, an international laboratory group with more than 61,000 employees in 61 countries, conducting more than 450 million tests annually.

Eurofins GeLaMed provides its customers with a wide range of high-quality services across eleven medical departments covering advanced and modern diagnostic options in human genetics, medical microbiology, laboratory medicine and molecular diagnostics. According to GeLaMed, its almost 500 employees process more than 15,000 orders per working day and offer more than 2,000 different analytical methods from their laboratory medicine and microbiology portfolios under the direction of medical specialists.

Marcus Cholewa, Business Line Director Clinical Diagnostics DACH at Eurofins, expressed excitement about the collaboration between Mainz Biomed and Eurofins GeLaMed, stating that Eurofins is always dedicated to delivering excellent customer service, quality, and advanced analytical solutions, as well as the most comprehensive range of testing methods. He also mentioned that Eurofins has a history of introducing innovative and high-value diagnostic testing products, and that by collaborating, they could assist in identifying colorectal cancer (CRC) and provide patients with personalized information to effectively manage their health.

Under the terms of the agreement, Eurofins GeLaMed will offer ColoAlert at its testing sites and Mainz Biomed will assist with physician and patient education programs as part of the product launch, highlighting the importance of early screening for the detection and prevention of CRC.

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 ( Gies 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 Cancer
Colorectal 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 NV
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 or follow us on LinkedIn , Twitter and Facebook .

For media inquiries, please contact [email protected]

In Europe:

MC Services AG
Anne Hennecke/Caroline Bergmann
+49 211 529252 20
[email protected]

In the US:

Spectrum Science
Melissa Laverty/Valerie Enes
+1 540 272 6465
[email protected]

For investor inquiries, please contact [email protected]

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 annual report on Form 20-F filed on May 5, 2022. The Company’s SEC filings are available publicly on the SEC’s website at 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.

BERKELEY, Calif. and MAINZ, Germany, May 01, 2023 (GLOBE NEWSWIRE) -- 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 its participation in the annual Digestive Disease Week (DDW) conference being held this year May 6-9 in Chicago, IL. DDW is the world’s premier meeting for digestive disease academic and industry professionals and throughout the Conference, members of Mainz Biomed’s executive team will be interacting with scientific and business leaders and will utilize the event to host a meeting of the Company’s Medical Advisory Board (MAB).

“As a company dedicated to bringing to market gold standard molecular diagnostics for the treatment and prevention of cancers including gastroenterological indications, we view DDW as an essential forum to remain current on technical innovation and industry trends,” commented Guido Baechler, Chief Executive Officer of Mainz Biomed. “We are also excited to host a formal meeting of our MAB during the conference to review company programs in development and discuss pipeline enhancement opportunities.”

Mainz Biomed is currently commercializing its flagship product ColoAlert ^® , a highly efficacious and easy-to-use detection test for colorectal cancer (CRC) in select international territories and in December of 2022, initiated a U.S. Pivotal Clinical Study (ReconAAsense) for a CRC screening test that may integrate the Company’s portfolio of novel gene expression (mRNA) biomarkers. These biomarkers have demonstrated potential to identify advanced adenomas, a type of curable pre-cancerous polyp often attributed to CRC that are being evaluated in European and U.S. studies (ColoFuture/eAArly DETECT). Results from both studies are expected in 2023 and Mainz Biomed anticipates enrollment in ReconAAsense to commence in mid-2023. The Company’s early-stage pipeline is highlighted by PancAlert, a potential first-in-class screening test for pancreatic cancer.

DDW brings together over 10,000 physicians, researchers and industry professionals comprising the digestive disease community. The Conference is jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy (ASGE) and the Society for Surgery of the Alimentary Tract (SSAT). The 2023 conference is an in-person and online meeting showcasing more than 3,100 abstracts and hundreds of lectures on the latest advances in GI research, medicine and technology. More information can be found at www.ddw.org .

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 ( Gies 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 Cancer
Colorectal 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 U.S.

About Mainz Biomed NV
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 marketed across Europe and the United Arab Emirates. The Company is currently 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 based on real-time Polymerase Chain Reaction-based (PCR) multiplex detection of molecular-genetic biomarkers in stool samples. To learn more, visit mainzbiomed.com or follow us on LinkedIn , Twitter and Facebook .

For media inquiries, please contact [email protected]
In Europe:
MC Services AG
Anne Hennecke/Caroline Bergmann
+49 211 529252 20
[email protected]

In the US:
Spectrum Science
Melissa Laverty/Valerie Enes
+1 540 272 6465
[email protected]

For investor inquiries, please contact [email protected]

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 20-F filed on May 5, 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.

BERKELEY, Calif. and MAINZ, Germany, April 27, 2023 (GLOBE NEWSWIRE) -- Mainz Biomed NV (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”), a molecular genetics diagnostic company specializing in the early detection of cancer, announces the following activities in May:

Commencement of Voluntary Quarterly Reporting:
Under the disclosure requirements of the U.S. NASDAQ listing, foreign issuers are required to disclose full year financial results (20-F). In addition, Mainz Biomed will commence voluntary quarterly reporting with the release of its Q1 2023 financial results. The Q1 results will be announced on May 16, 2023.

Presentation at Equity Forum Spring Conference 2023:
CEO Guido Baechler will present at the Equity Forum Spring Conference 2023 in Frankfurt, Germany, on Wednesday, May 17, 2023, and will be available for meetings with investors at the Forum on Tuesday and Wednesday, May 16 & 17:

Equity Forum Spring Conference 2023
May 15-17, 2023
Frankfurt am Main, Germany, Le Meridien
Company presentation: May 17, Session I, 7:45 a.m. ET
https://equityforum.de/events/fr-hjahrskonferenz-2023

"After a successful start to the year with the expansion of sales activities in Germany, the commencement of new laboratory partnerships and the development of further European markets, we are focused on implementing our strategy to expand our commercial business in Europe and to advance the approval process in the US, as announced. The Board and Management are committed to continue to execute the business plan to grow shareholder value. I look forward to the upcoming results of our eAArly Detect study to demonstrate the potential of our new biomarkers and also to face-to-face interactions with existing and potential new investors," said Guido Baechler, Chief Executive Officer of Mainz Biomed.

Mainz Biomed is currently commercializing its flagship product ColoAlert ^® , a highly efficacious and easy-to-use detection test for colorectal cancer (CRC) in select international territories and in December of 2022, initiated a U.S. Pivotal Clinical Study (ReconAAsense) for a CRC screening test that may integrate the Company’s portfolio of novel gene expression (mRNA) biomarkers. These biomarkers have demonstrated potential to identify advanced adenomas, a type of pre-cancerous polyp often attributed to CRC that are being evaluated in European and U.S. studies (ColoFuture/eAArly DETECT). Results from eAArly DETECT are expected in mid-2023 and Mainz Biomed anticipates enrollment in ReconAAsense to commence in the second half of 2023.  The Company’s early-stage pipeline is highlighted by PancAlert, a potential first-in-class screening test for pancreatic cancer.

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 ( Gies 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 Cancer
Colorectal 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 NV
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 or follow us on LinkedIn , Twitter and Facebook .

For media inquiries, please contact [email protected]

In Europe:
MC Services AG
Anne Hennecke/Caroline Bergmann
+49 211 529252 20
[email protected]

In the US:
Spectrum Science
Melissa Laverty/Valerie Enes
+1 540 272 6465
[email protected]

For investor inquiries, please contact [email protected]

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 annual report on Form 20-F filed on May 5, 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.

BERKELEY, Calif. and MAINZ, Germany, April 26, 2023 (GLOBE NEWSWIRE) -- Mainz Biomed NV (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”), a molecular genetics diagnostic company specializing in the early detection of cancer, announced that it has added the Instituto de Microecologia in Madrid to its growing network of lab partners across Europe and in select international markets. ColoAlert ^® , Mainz Biomed’s flagship product, is a highly efficacious and easy-to-use, at-home detection test for colorectal cancer (CRC). For more than 60 years, the Instituto de Microecologia has been a pioneer in microbiota studies and food sensitivity, focused on disseminating the importance of intestinal health through microbiological analysis and diagnosis of microbiota profiles and specific health parameters. Entering the market and beginning commercialization in Spain and Portugal signify the continued expansion of Mainz Biomed’s impact in Europe.

“As we continue to form partnerships with third-party diagnostic labs such as the Instituto de Microecologia for test kit processing, our aim is to increase consumer access to affordable and reliable CRC screening tests like ColoAlert,” said Guido Baechler, Chief Executive Officer of Mainz Biomed. “Early screening has the potential to dramatically impact the treatment and prevention of this deadly disease, as well as save lives.”

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 41,441 new cases each year affecting 1 in 20 men and 1 in 30 women before the age of 74. The probability of survival exceeds 90% when detected at an early stage.

The Instituto de Microecologia is widely known across Spain for its pioneering work in intestinal health. It 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.

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 ( Gies 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 Cancer
Colorectal 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 NV
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 or follow us on LinkedIn , Twitter and Facebook .

For media inquiries, please contact [email protected]

In Europe:
MC Services AG
Anne Hennecke/Caroline Bergmann
+49 211 529252 20
[email protected]

In the US:
Spectrum Science
Melissa Laverty/Valerie Enes
+1 540 272 6465
[email protected]

For investor inquiries, please contact [email protected]

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 annual report on Form 20-F filed on May 5, 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.