Mainz Biomed Announces Strategic Partnership with Ärztliches Labor Dr. Buhlmann, Expanding Footprint in German Market

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 strategic partnership with Ärztliches Labor Dr. Buhlmann, a move aimed at further strengthening its position in the German market.

The collaboration grants Mainz Biomed greater access to, and the potential for further expansion into Germany's private health insurance segment where ColoAlert®, its highly efficacious, and easy-to-use detection test for colorectal cancer (CRC), already receives reimbursement.

Established in 2006 and led by Dr. Annette Buhlmann, a seasoned expert with over 25 years of experience in laboratory medicine, Ärztliches Labor Dr. Buhlmann is a respected player in PCR-based analysis. Its comprehensive services include molecular diagnostics, genetics, HLA testing, and infectious disease assessments, catering to a diverse clientele spanning statutory and private insurance segments.

Given that approximately 10.5% of Germany's population, or roughly 8.7 million individuals, are covered by private health insurance (PHI), as estimated by the Association of Substitute Health Insurance Funds (vdek) in 2022, the partnership expands a strong market channel for Mainz Biomed. Moreover, a substantial portion of these PHI beneficiaries fall within the critical 50-74 age range, the target demographic for CRC screening in Germany.

Darin Leigh, Chief Commercial Officer of Mainz Biomed, expressed optimism about the collaboration, stating, “Our steadfast commitment to integrating ColoAlert into Germany’s statutory health insurance reimbursement framework underscores our growth aspirations. Partnering with Dr. Buhlmann's laboratory not only has the potential to further expedite the adoption of ColoAlert in Germany, but also aligns with our core mission of facilitating early CRC detection globally. We look forward to leveraging her network across both public and private sectors and benefitting from her considerable expertise in pioneering molecular diagnostic tests.”

Dr. Buhlmann also shared her enthusiasm, saying, “ColoAlert's innovative approach has the potential to dramatically improve CRC testing. Its capacity to identify DNA biomarkers represents a significant enhancement to the conventional iFOBT (Fecal Occult Blood Test) tests, promising convenience and precision for patients. There’s a pressing need to enable improved access to alternative testing options for early CRC detection and therefore we are dedicated to championing the benefits of ColoAlert, not only in Germany but also across European markets, with physicians, health authorities and private clients.”

About ColoAlert®ColoAlert®, Mainz Biomed’s flagship product, delivers high sensitivity and specificity in a user-friendly, at-home colorectal cancer (CRC) screening kit. This non-invasive test can be indicative of tumors as determined by analyzing tumor DNA, offering better early detection than fecal occult blood tests (FOBT). Based on PCR-technology, ColoAlert® detects more cases of colorectal cancer than other stool tests and allows for an earlier diagnosis (Dollinger et al., 2018). The product is commercially available in select EU countries through a network of leading independent laboratories, corporate health programs and via direct sales. To receive marketing approval in the US, ColoAlert® will be evaluated in the FDA-registration trial “ReconAAsense.” Once approved in the US, the Company’s commercial strategy is to establish scalable distribution through a collaborative partner program with regional and national laboratory service providers across the country.

About Colorectal CancerColorectal cancer (CRC) is the third most common cancer globally, with more than 1.9 million new cases reported in 2020, according to World Cancer Research Fund International. The US Preventive Services Task Force recommends that screening with stool DNA tests such as ColoAlert® should be conducted once every three years starting at age 45. Each year in the US, 16.6 million colonoscopies are performed. However, roughly one-third of US residents aged 50-75 have never been screened for colon cancer. This gap in screening represents a $4.0B+ total market opportunity in the US.

About Mainz Biomed NVMainz 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/X and Facebook.

Forward-Looking StatementsCertain statements made in this press release are “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words such as “anticipate,” “believe,” “expect,” “estimate,” “plan,” “outlook” and “project,” and other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements reflect the current analysis of existing information and are subject to various risks and uncertainties. As a result, caution must be exercised in relying on forward-looking statements. Due to known and unknown risks, actual results may differ materially from the Company’s expectations or projections. The following factors, among others, could cause actual results to differ materially from those described in these forward-looking statements: (i) the failure to meet projected development and related targets; (ii) changes in applicable laws or regulations; (iii) the effect of the COVID-19 pandemic on the Company and its current or intended markets; and (iv) other risks and uncertainties described herein, as well as those risks and uncertainties discussed from time to time in other reports and other public filings with the Securities and Exchange Commission (the “SEC”) by the Company. Additional information concerning these and other factors that may impact the Company’s expectations and projections can be found in its initial filings with the SEC, including its annual report on Form 20-F filed on April 7, 2023. The Company’s SEC filings are available publicly on the SEC’s website at 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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