Mainz Biomed Announces Live Launch of ColoAlert® with Marylebone Laboratory in the United Kingdom

Mainz Biomed Announces Live Launch of ColoAlert^® with Marylebone Laboratory in the United Kingdom

Collaborative Partnership Strengthens Mainz Biomed's Mission to Combat Colorectal Cancer, Saving Lives through Advanced Diagnostics

BERKELEY, US – MAINZ, Germany – August 01, 2023 — 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 London-based Marylebone Laboratory (Marylebone Lab Ltd) has introduced ColoAlert®, Mainz Biomed’s flagship product—a highly effective and user-friendly at-home detection test for colorectal cancer (CRC) - to its extensive UK and international customer base.

Further strengthening Mainz Biomed’s global network of esteemed laboratory partners, the collaboration marks another significant milestone in the Company’s mission to combat colorectal cancer (CRC) and save lives through advanced diagnostics. Colorectal cancer remains a critical health concern, with approximately 43,000 diagnoses and 16,800 deaths occurring each year in the UK alone. This equates to an average of 46 lives lost every day.

With a population of 67 million people, the UK, presents a substantial market for CRC screening. Specifically, within the age groups of 40 to 49 years and 50 to 75 years, there are approximately 8.4 million and 20.0 million individuals respectively. Additionally, there are 6.2 million individuals aged over 75. With a recommended frequency of CRC screening once every two years for patients aged 50 to 74, ColoAlert® represents a pivotal tool in the fight against this devastating disease. Considering these figures, the addressable UK market for ColoAlert® amounts to a staggering 34.6 million potential users.

Mainz Biomed is delighted to collaborate with Marylebone Laboratory, which recently expanded its presence in London, under the Marylebone Diagnostic Centre brand where it provides a comprehensive range of screening and diagnostic testing services. Marylebone Laboratory brings extensive expertise in NGS (Next-Generation Sequencing) and PCR (Polymerase Chain Reaction)-based molecular genetic testing. Its focus on innovative methodologies allows for tailored solutions to individual customers as well as larger organizations and ensures the delivery of state-of-the-art genetic-based testing services.

“With our significant experience in both NGS and PCR based molecular genetic testing, we are thrilled to offer ColoAlert® to our UK-based and international customer network,” said Thomas Bianchi, Director of the Centre. “Colorectal cancer is the fourth most common cancer in the UK and the third worldwide and ColoAlert®’s unique genetic-based solution has the potential to provide a step change in how we’re able to provide life-changing early diagnosis.”

Darin Leigh, Chief Commercial Officer of Mainz Biomed, expressed his excitement about this partnership, stating “With Marylebone, we are pleased that we have found a strong strategic partner in the UK market. The organization is committed to bringing the very best CRC screening solutions to the UK population to reduce the number of late CRC diagnoses, thereby increasing patient survival and reducing the burden of medical treatment.”

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 investor inquiries, please contact info@mainzbiomed.com

For media inquiries, please contact press@mainzbiomed.com

In Europe:
MC Services AG
Anne Hennecke/Caroline Bergmann
+49 211 529252 20
mainzbiomed@mc-services.eu

In the US:
Josh Stanbury
416-628-7441
josh@sjspr.co

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.